Clinical Trials

Numerous clinical trials evaluate mitoxantrone across diverse oncological and autoimmune indications, spanning Phase 1 through Phase 4 studies for acute myeloid leukemia, diffuse large B-cell lymphoma, breast cancer, advanced solid tumors, and relapsing multiple sclerosis. Sponsored by academic institutions such as the University of Chicago and pharmaceutical developers including CSPC ZhongQi Pharmaceutical Technology Co. Ltd., these protocols encompass recruitment statuses ranging from active and completed trials to terminated or withdrawn studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02724163 ACTIVE_NOT_RECRUITING
Acute Myeloid Leukaemia
University of Birmingham
2016-04 PHASE3
NCT07754799 NOT_YET_RECRUITING
Acute Myeloid Leukemia (AML)
Institute of Hematology & Blood Diseases Hospital, China
2026-09-30 PHASE2
NCT04293562 RECRUITING
Acute Myeloid Leukemia
Children's Oncology Group
2020-07-21 PHASE3
NCT03591510 ACTIVE_NOT_RECRUITING
FLT3-mutated Acute Myeloid Leukemia
Novartis Pharmaceuticals
2019-03-13 PHASE2
NCT05848687 RECRUITING
Lymphoblastic Leukemia
Tanja Andrea Gruber
2023-11-03 PHASE1; PHASE2
NCT06221683 RECRUITING
AML, Childhood; Acute Myeloid Leukemia
Children's Hospital of Soochow University
2024-01-01 PHASE2
NCT07725705 NOT_YET_RECRUITING
PTCL; First Line Treatment
Institute of Hematology & Blood Diseases Hospital, China
2026-08-01 PHASE1; PHASE2
NCT07168317 RECRUITING
New Diagnosed Angioimmunoblastic T-Cell Lymphoma
The Affiliated Hospital of Xuzhou Medical University
2025-08-01 PHASE2
NCT07735117 NOT_YET_RECRUITING
Acute Myeloid Leukemia (AML); Myelodysplastic Syndromes (MDS)
Ruijin Hospital
2026-07-30 PHASE3
NCT06262438 RECRUITING
Acute Myeloid Leukemia in Children
Princess Maxima Center for Pediatric Oncology
2024-02-06 PHASE2
NCT07131059 RECRUITING
AML, Adult
Institute of Hematology & Blood Diseases Hospital, China
2024-05-11
NCT07058103 RECRUITING
Angioimmunoblastic T-Cell Lymphoma Recurrent; Angioimmunoblastic T-Cell Lymphoma Refractory
The Affiliated Hospital of Xuzhou Medical University
2025-04-01 PHASE2
NCT07525466 RECRUITING
Extranodal NK T Cell Lymphoma; Hemophagocytic Lymphohistiocytosis (HLH)
Beijing Tongren Hospital
2026-04-01 PHASE1; PHASE2
NCT07354698 NOT_YET_RECRUITING
Papillary Thyroid Cancer
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
2026-02-01 PHASE4
NCT06265545 RECRUITING
AML; Refractory; Relapsed
Institute of Hematology & Blood Diseases Hospital, China
2024-02-22
NCT07372352 RECRUITING
Peripheral T Cells Lymphoma (PTCL)
The First Affiliated Hospital of Soochow University
2026-01-15 PHASE2
NCT04797767 RECRUITING
Acute Biphenotypic Leukemia; Acute Myeloid Leukemia; Mixed Phenotype Acute Leukemia; Myeloid Neoplasm; Relapsed Acute Biphenotypic Leukemia; Relapsed Acute Myeloid Leukemia; Relapsed Mixed Phenotype Acute Leukemia; Relapsed Myeloid Neoplasm; Refractory Acute Biphenotypic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Mixed Phenotype Acute Leukemia; Refractory Myeloid Neoplasm; Recurrent Myeloid Sarcoma
University of Washington
2022-02-04 PHASE1; PHASE2
NCT06621199 RECRUITING
Acute Myeloid Leukemia
First Affiliated Hospital of Zhejiang University
2024-07-08 PHASE2
NCT04668690 ACTIVE_NOT_RECRUITING
Peripheral T Cell Lymphoma
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2021-04-13 PHASE3
NCT06660368 RECRUITING
Relapsed or Refractory Acute Myeloid Leukemia (AML)
H. Lee Moffitt Cancer Center and Research Institute
2024-11-26 PHASE2
NCT07389356 NOT_YET_RECRUITING
DLBCL - Diffuse Large B Cell Lymphoma
The First Affiliated Hospital with Nanjing Medical University
2026-02-25
NCT07093710 RECRUITING
Peripheral T Cell Lymphoma
Sun Yat-sen University
2025-08-27 PHASE1; PHASE2
NCT03983824 ACTIVE_NOT_RECRUITING
Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
National Cancer Institute (NCI)
2020-05-05 PHASE1
NCT06447090 RECRUITING
Relapse Acute Myeloid Leukemia
Institute of Hematology & Blood Diseases Hospital, China
2024-04-12 PHASE2
NCT05330377 WITHDRAWN
Acute Myeloid Leukemia
Ayman H Qasrawi
2023-03 PHASE1
NCT06761417 RECRUITING
Solid Tumors; Children; Adolescents
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
2025-01-24 PHASE2
NCT04375631 RECRUITING
Recurrent Acute Myeloid Leukemia; Recurrent Chronic Myelomonocytic Leukemia; Recurrent Myelodysplastic Syndrome; Refractory Acute Myeloid Leukemia; Refractory Chronic Myelomonocytic Leukemia; Refractory Mixed Phenotype Acute Leukemia; Refractory Myelodysplastic Syndrome; Refractory Acute Leukemia of Ambiguous Lineage; Refractory Acute Undifferentiated Leukemia
Fred Hutchinson Cancer Center
2020-12-03 PHASE1
NCT07070479 RECRUITING
Recurrent or Metastatic Nasopharyngeal Carcinoma
Ming-Yuan Chen
2025-06-24 PHASE2
NCT06621212 RECRUITING
Relapsed/Refractory Acute Myeloid Leukaemia; Myeloid Malignancy
First Affiliated Hospital of Zhejiang University
2024-07-05 PHASE2
NCT07288814 NOT_YET_RECRUITING
Relapsed or Refractory Peripheral T Cell Lymphoma
Sun Yat-Sen University Cancer Center
2025-12-08 PHASE1; PHASE2
NCT06345365 RECRUITING
Acute Myeloid Leukaemia
Zhongnan Hospital
2024-01-18 PHASE3
NCT05603884 RECRUITING
Leukemia, Myeloid, Acute; AML Stage, Adult
The First Affiliated Hospital of Xiamen University
2022-12-01 PHASE2
NCT06385808 NOT_YET_RECRUITING
Relapse Leukemia; Refractory Acute Myeloid Leukemia; Conditioning; Hematopoietic Stem Cell Transplantation
First Affiliated Hospital Xi'an Jiaotong University
2024-05-01
NCT07486479 NOT_YET_RECRUITING
Acute Myeloid Leukemia (AML)
The First Affiliated Hospital of Soochow University
2026-03-10 PHASE3
NCT05681403 NOT_YET_RECRUITING
Lymphoma; Autologous Hematopoietic Stem Cell Transplantation
First Affiliated Hospital Xi'an Jiaotong University
2023-01-15
NCT06651866 RECRUITING
Acute Myeloid Leukemia
The First Affiliated Hospital of Xiamen University
2024-12-12 PHASE1
NCT06489808 RECRUITING
Relapsed/Refractory Large B-Cell Lymphoma
Institute of Hematology & Blood Diseases Hospital, China
2024-05-28 PHASE2
NCT06499025 ENROLLING_BY_INVITATION
AML; t(8;21); Neoantigen
BGI, China
2024-02-01 EARLY_PHASE1
NCT05958719 RECRUITING
Peripheral T Cell Lymphoma; Epigenetic Repression
Institute of Hematology & Blood Diseases Hospital, China
2023-03-02 PHASE2
NCT05955261 SUSPENDED
Acute Myeloid Leukemia
St. Jude Children's Research Hospital
2023-07-25 PHASE2
NCT06429449 RECRUITING
Leukemia; Myeloid Leukemia; Monocytic Leukemia
University of Colorado, Denver
2024-07-21 PHASE1
NCT03258320 RECRUITING
Prostate Cancer Patients
Shanghai Jiao Tong University School of Medicine
2015-01 PHASE2; PHASE3
NCT06741722 RECRUITING
AML; Relapsed Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
Beijing 302 Hospital
2024-10-31 PHASE2
NCT07490288 RECRUITING
AML
Institute of Hematology & Blood Diseases Hospital, China
2026-05-08
NCT06758726 NOT_YET_RECRUITING
AML
Institute of Hematology & Blood Diseases Hospital, China
2024-12-31
NCT05717764 NOT_YET_RECRUITING
Recurrent Metastatic Nasopharyngeal Carcinoma
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
2023-02 PHASE3
NCT06514313 RECRUITING
Soft Tissue Sarcoma
Yizhuo Zhang
2024-07-03 PHASE2
NCT06594640 RECRUITING
Diffuse Large B-cell Lymphoma
Institute of Hematology & Blood Diseases Hospital, China
2024-05-30 PHASE1; PHASE2
NCT07028086 RECRUITING
Acute Myeloid Leukemia; Myeloid Sarcoma
Ruijin Hospital
2025-06-20 PHASE2
NCT03250338 COMPLETED
Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Arog Pharmaceuticals, Inc.
2018-08-16 PHASE3
NCT05313958 UNKNOWN
Leukemia, Monocytic, Acute; Pediatric AML
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
2021-12-01 PHASE2; PHASE3
NCT06921044 NOT_YET_RECRUITING
Diffuse Large B-Cell Lymphoma
Xiaohui He
2025-04-16 PHASE2
NCT03926624 TERMINATED
Leukemia, Myeloid, Acute
Delta-Fly Pharma, Inc.
2019-11-22 PHASE3
NCT06329999 RECRUITING
Recurrent Adult Acute Myeloid Leukemia; Myelodysplastic Syndrome; Adult Acute Myeloid Leukemia
Ruijin Hospital
2024-02-03
NCT06892431 NOT_YET_RECRUITING
Recurrent or Metastatic Nasopharyngeal Cancer; Patients Who Have Experienced Treatment Failure at Least Second-line Chemotherapy
Shanghai JMT-Bio Inc.
2025-04-01 PHASE2
NCT05814718 UNKNOWN
Autologous Stem Cell Transplantation; Conditioning
First Affiliated Hospital Xi'an Jiaotong University
2023-04-15
NCT06244368 RECRUITING
Peripheral T Cell Lymphoma; Diffuse Large B-cell Lymphoma
Institute of Hematology & Blood Diseases Hospital, China
2024-01-17 PHASE2
NCT06007911 WITHDRAWN
Relapsed Adult AML; Refractory AML
Medical College of Wisconsin
2024-08-31 PHASE1
NCT06246162 RECRUITING
Multiple Myeloma
Affiliated Hospital of Nantong University
2023-11-13 PHASE1; PHASE2
NCT05522192 UNKNOWN
Relapsed or Refractory Acute Myeloid Leukemia
Hui Zeng
2022-07-21 PHASE1; PHASE2
NCT06472713 RECRUITING
Recurrent or Metastatic Nasopharyngeal Carcinoma
Ming-Yuan Chen
2024-07-20 PHASE2
NCT06211881 UNKNOWN
Relapsed/Refractory Peripheral T-cell Lymphoma
The First Affiliated Hospital with Nanjing Medical University
2023-10-25
NCT03164057 ACTIVE_NOT_RECRUITING
Acute Myeloid Leukemia; Myelodysplastic Syndromes
St. Jude Children's Research Hospital
2017-06-15 PHASE2
NCT06486337 NOT_YET_RECRUITING
NHL
The First Affiliated Hospital of Soochow University
2024-07-10 PHASE2
NCT06475287 UNKNOWN
Hepatocellular Carcinoma
Fudan University
2024-07-20 PHASE2
NCT05575973 UNKNOWN
Diffuse Large B-cell Lymphoma
Jianfeng Zhou
2022-10-10 PHASE2
NCT06433362 UNKNOWN
Peripheral T Cell Lymphoma
Tianjin Medical University Cancer Institute and Hospital
2024-06-01 PHASE2
NCT04195945 COMPLETED
Acute Myeloid Leukemia; Myeloid Neoplasm
Fred Hutchinson Cancer Center
2020-05-27 PHASE2
NCT07764653 COMPLETED
Sentinel Nodes; Breast Cancer
HTA Co., Ltd.
2024-01-02 PHASE3
NCT06434662 UNKNOWN
Relapsed/Refractory Acute Myeloid Leukaemia; Myeloid Malignancy
First Affiliated Hospital of Zhejiang University
2024-02-29 PHASE2
NCT05441761 UNKNOWN
Treatment; Peripheral T-cell Lymphoma
Peking Union Medical College Hospital
2022-05-01 PHASE1; PHASE2
NCT05464433 ACTIVE_NOT_RECRUITING
Extranodal Natural Killer T Cell Lymphoma
Sun Yat-sen University
2022-06-23 PHASE1; PHASE2
NCT03150004 TERMINATED
Acute Myeloid Leukemia; Myelodysplastic Syndrome
Medical College of Wisconsin
2017-06-14 PHASE2
NCT05857982 UNKNOWN
Relapsed/Refractory Multiple Myeloma
Second Affiliated Hospital of Soochow University
2023-05-20 PHASE1; PHASE2
NCT02688140 COMPLETED
Acute Promyelocytic Leukemia
Technische Universität Dresden
2016-06 PHASE3
NCT05941585 COMPLETED
Acute Myeloid Leukemia
Institute of Hematology & Blood Diseases Hospital, China
2023-08-08
NCT05875428 UNKNOWN
Diffuse Large B-Cell Lymphoma
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2023-07-10 PHASE2
NCT05458180 UNKNOWN
Peripheral T-cell Lymphoma
Tianjin Medical University Cancer Institute and Hospital
2022-07-07 PHASE1
NCT06224842 UNKNOWN
Angioimmunoblastic T-cell Lymphoma
Huijing Wu
2023-12-12 PHASE1; PHASE2
NCT05620862 UNKNOWN
Pediatric Solid Tumor
Sun Yat-sen University
2022-10-25 PHASE1
NCT05527275 UNKNOWN
Relapsed and Refractory Peripheral T-cell Lymphoma
Sun Yat-sen University
2022-10-01 PHASE1; PHASE2
NCT06220097 ACTIVE_NOT_RECRUITING
B-cell Acute Lymphoblastic Leukemia; B-cell Lymphoma Refractory
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
2022-02-01 PHASE2
NCT05990985 UNKNOWN
Diffuse Large B-cell Lymphoma
The First Hospital of Jilin University
2023-09-01
NCT05551598 COMPLETED
Neuromyelitis Optica Spectrum Disorder
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
2022-11-28 PHASE2
NCT02521493 ACTIVE_NOT_RECRUITING
Acute Myeloid Leukemia; Down Syndrome; Myelodysplastic Syndrome; Myeloid Leukemia Associated With Down Syndrome; Myeloproliferative Neoplasm
Children's Oncology Group
2015-12-23 PHASE3
NCT02303821 COMPLETED
Acute Lymphoblastic Leukemia (ALL)
Amgen
2015-02-16 PHASE1
NCT03441048 COMPLETED
Acute Myeloid Leukemia
Medical College of Wisconsin
2018-05-22 PHASE1
NCT05774028 UNKNOWN
NK-T-Cell Lymphoma, Extranodal
The First Affiliated Hospital with Nanjing Medical University
2023-04 PHASE2
NCT06156761 UNKNOWN
Breast Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
2023-11-28
NCT04778410 TERMINATED
Myeloid Malignancies
Gilead Sciences
2021-06-28 PHASE2
NCT05344742 UNKNOWN
Advanced Solid Tumor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2022-04 PHASE1
NCT05739630 UNKNOWN
Acute Leukemia
The First Affiliated Hospital of Soochow University
2023-01-01 PHASE2; PHASE3
NCT05784987 UNKNOWN
Diffuse Large B-cell Lymphoma
The First Affiliated Hospital with Nanjing Medical University
2023-04-15
NCT05823701 UNKNOWN
Diffuse Large B-Cell Lymphoma
The First Affiliated Hospital of Soochow University
2022-09-30 PHASE2
NCT03182244 ACTIVE_NOT_RECRUITING
AML With FLT3 Mutation
Astellas Pharma Inc
2017-10-25 PHASE3
NCT05299164 ACTIVE_NOT_RECRUITING
Non Hodgkin Lymphoma
Institute of Hematology & Blood Diseases Hospital, China
2022-05-15 PHASE1
NCT03026842 UNKNOWN
Acute Myeloid Leukemia
The First Hospital of Jilin University
2017-01 PHASE4
NCT05772728 UNKNOWN
T Cell Lymphoma
The First Affiliated Hospital with Nanjing Medical University
2023-04
NCT05100329 UNKNOWN
Advanced Pancreatic Cancer
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2021-11 PHASE2
NCT06156761 Not yet recruiting
Breast Cancer
Cancer Institute and Hospital Chinese Academy of Medical Sciences|CSPC Ouyi Pharmaceutical Co. Ltd.
2023-11-28 Not Applicable
NCT03576378 UNKNOWN
Hodgkin Lymphoma
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
2018-08-08 PHASE1; PHASE2
NCT04902027 COMPLETED
Recurrent Head and Neck Cancer; Metastatic Head and Neck Cancer
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2021-07-01 PHASE1
NCT04330820 COMPLETED
Relapsed Adult AML; Refractory AML
Technische Universität Dresden
2020-04-06 PHASE1; PHASE2
NCT02910752 SUSPENDED
Leukemia
Shanghai Jiao Tong University School of Medicine
2016-09 PHASE1; PHASE2
NCT05495100 UNKNOWN
Peripheral T Cell Lymphoma
Second Affiliated Hospital, Zhejiang University, School of Medicine
2022-08-11 PHASE2
NCT05777369 UNKNOWN
Diffuse Large B-cell Lymphoma
The First Affiliated Hospital with Nanjing Medical University
2023-03
NCT05875428 Recruiting
Diffuse Large B-Cell Lymphoma
CSPC ZhongQi Pharmaceutical Technology Co. Ltd.
2023-07-10 Phase 2
NCT04548700 TERMINATED
Treatment-naïve; Peripheral T Cell Lymphoma
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2020-12-24 PHASE1
NCT04718376 TERMINATED
Platinum-resistant Ovarian Cancer
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2021-01-12 PHASE1
NCT04331743 UNKNOWN
Advanced Hepatocellular Carcinoma
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2021-06-05 PHASE1
NCT05052970 UNKNOWN
Relapsed or Refractory Multiple Myeloma
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
2021-10-20 PHASE1
NCT02583893 COMPLETED
Recurrent Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
2015-10-07 PHASE2
NCT04921878 COMPLETED
Advanced Solid Tumors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2021-07-30 PHASE1
NCT04900766 TERMINATED
Unresectable or Metastatic Bone and Soft Tissue Sarcoma
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2021-08-11 PHASE1
NCT03839446 COMPLETED
Acute Myeloid Leukemia
Robert Redner, MD
2019-02-28 PHASE2
NCT04927481 TERMINATED
Breast Cancer
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2021-06-11 PHASE2
NCT05345938 TERMINATED
Relapsed or Refractory Acute Myeloid Leukemia (AML)
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2022-06-14 PHASE1; PHASE2
NCT01065727 COMPLETED
Multiple Sclerosis
Rennes University Hospital
2010-03
NCT05496894 WITHDRAWN
Relapsing Multiple Sclerosis
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
2022-08 PHASE2
NCT05100303 UNKNOWN
Treatment-naive or Relapsed or Refractory Acute Myeloid Leukemia (AML)
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2021-12 PHASE1; PHASE2
NCT03860844 TERMINATED
Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia
Sanofi
2019-08-06 PHASE2
NCT03989713 TERMINATED
AML According to WHO 2016 Classification (Except Acute Promyelocytic Leukemia) AND (Refractory to Induction Therapy OR Relapsed After First Line Treatment)
Prof. Dr. Richard F Schlenk
2020-07-17 PHASE2
NCT05496894 Withdrawn
Relapsing Multiple Sclerosis
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd.
2022-08 Phase 2
NCT05089461 SUSPENDED
Advanced Malignant Tumor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2022-03-07 PHASE2
NCT04718402 TERMINATED
Advanced Gastric Carcinoma
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2021-03-30 PHASE1
NCT02553460 ACTIVE_NOT_RECRUITING
Acute Lymphoblastic Leukemia
St. Jude Children's Research Hospital
2016-01-29 PHASE1; PHASE2
NCT04719065 UNKNOWN
Advanced Solid Tumor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2021-01-13 PHASE1
NCT02461537 COMPLETED
Acute Myeloid Leukemia
DKMS gemeinnützige GmbH
2015-09-17 PHASE3
NCT02728050 COMPLETED
Acute Biphenotypic Leukemia; Acute Myeloid Leukemia; de Novo Myelodysplastic Syndrome; Myelodysplastic Syndrome; Myeloproliferative Neoplasm
University of Washington
2016-12-01 PHASE1; PHASE2
NCT04509466 TERMINATED
Extranodal NK/T-cell Lymphoma, Nasal Type
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2020-09-15 PHASE1; PHASE2
NCT04352413 TERMINATED
Small Cell Lung Cancer
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2020-06-18 PHASE2
NCT02523976 COMPLETED
Acute,Leukemia, Lymphoid
Institute of Hematology & Blood Diseases Hospital, China
2015-08-01 PHASE2
NCT02687386 TERMINATED
Solid Tumours; CNS Tumours
Dr David Ziegler
2016-02-08 PHASE1
NCT03504410 TERMINATED
Relapsed/Refractory Acute Myeloid Leukemia
Cornerstone Pharmaceuticals
2018-11-12 PHASE3
NCT04196010 TERMINATED
Myeloid Neoplasm; Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
University of Washington
2020-05-08 PHASE1
NCT02200978 COMPLETED
Childhood Acute Promyelocytic Leukemia
South China Children's Leukemia Group
2011-09 PHASE4
NCT01842672 COMPLETED
Acute Lymphoblastic Leukemia; Acute Myelogenous Leukemia; Lymphoblastic Lymphoma; Diffuse Large B-cell Lymphoma; Burkitt Lymphoma/Leukemia
New York Medical College
2013-03 PHASE1; PHASE2
NCT01700946 COMPLETED
Recurrent B-Cell Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood B-Lymphoblastic Lymphoma
St. Jude Children's Research Hospital
2013-04-15 PHASE2
NCT03531918 COMPLETED
Acute Myeloid Leukemia
Fred Hutchinson Cancer Center
2018-09-14 PHASE1; PHASE2
NCT02101853 ACTIVE_NOT_RECRUITING
Recurrent B Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
2014-12-17 PHASE3
NCT00712582 COMPLETED
Non-Hodgkin's Lymphoma
Memorial Sloan Kettering Cancer Center
2008-07-01 PHASE2
NCT00290511 COMPLETED
Lymphoma
M.D. Anderson Cancer Center
2004-06-29 PHASE2
NCT03776279 UNKNOWN
Relapsed or Refractory Peripheral T-cell and NK/T-cell Lymphoma
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2018-04-02 PHASE2
NCT03012672 COMPLETED
Acute Leukemia of Ambiguous Lineage; Acute Myeloid Leukemia; Myeloid Neoplasm
University of Washington
2016-12-30 PHASE2
NCT02848183 UNKNOWN
Pediatric Acute Myeloid Leukemia
Samsung Medical Center
2016-01 PHASE2
NCT00550992 UNKNOWN
Leukemia
Dutch Childhood Oncology Group
2006-01
NCT02339740 ACTIVE_NOT_RECRUITING
Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA
Children's Oncology Group
2015-07-21 PHASE3
NCT05173545 COMPLETED
Recurrent/Refractory Lymphoma
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2019-07-29 PHASE1
NCT02400281 COMPLETED
Acute Myeloid Leukemia
Arog Pharmaceuticals, Inc.
2015-09 PHASE1; PHASE2
NCT02937285 COMPLETED
Multiple Sclerosis
Rennes University Hospital
2010-12-06 PHASE3
NCT02733380 UNKNOWN
Diffuse Large B-cell Lymphoma
Henan Cancer Hospital
2016-05 PHASE2
NCT03563560 COMPLETED
Acute Myeloid Leukemia
Sumitomo Pharma Co., Ltd.
2018-05-15 PHASE1
NCT02298166 TERMINATED
Acute Myeloid Leukemia
University of Ulm
2016-11-17 PHASE3
NCT02756572 COMPLETED
Blasts 10 Percent or More of Bone Marrow Nucleated Cells; Chronic Myelomonocytic Leukemia-2; High Grade Malignant Neoplasm; Myelodysplastic Syndrome; Myelodysplastic Syndrome With Excess Blasts-2; Myeloid Neoplasm; Previously Treated Myelodysplastic Syndrome; Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
University of Washington
2016-09-22 PHASE2
NCT02520011 TERMINATED
Acute Myeloid Leukemia
Sumitomo Pharma America, Inc.
2016-03-14 PHASE2
NCT03118466 COMPLETED
AML
Massachusetts General Hospital
2017-09-25 PHASE2
NCT01839240 COMPLETED
Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia
University of Chicago
2012-06-06 PHASE1
NCT01371981 COMPLETED
Acute Myeloid Leukemia; Leukemia Cutis; Myeloid Neoplasm; Myeloid Sarcoma
National Cancer Institute (NCI)
2011-07-06 PHASE3
NCT03735446 TERMINATED
Acute Myeloid Leukemia; Myelodysplastic Syndromes
Dana-Farber Cancer Institute
2019-01-18 PHASE1
NCT02632708 ACTIVE_NOT_RECRUITING
Newly Diagnosed Acute Myeloid Leukemia (AML); Untreated AML; AML Arising From Myelodysplastic Syndrome (MDS); AML Arising From Antecedent Hematologic Disorder (AHD); AML Arising After Exposure to Genotoxic Injury
Institut de Recherches Internationales Servier
2015-12-31 PHASE1
NCT02921061 COMPLETED
Mixed Phenotype Acute Leukemia; Previously Treated Myelodysplastic Syndrome; Recurrent Adult Acute Myeloid Leukemia; Recurrent High Risk Myelodysplastic Syndrome; Refractory Acute Myeloid Leukemia; Refractory High Risk Myelodysplastic Syndrome; Untreated Adult Acute Myeloid Leukemia
Fred Hutchinson Cancer Center
2016-11-17 PHASE1; PHASE2
NCT02484391 COMPLETED
Granulocytic Sarcoma; Recurrent Adult Acute Myeloid Leukemia
Wake Forest University Health Sciences
2015-09 PHASE1
NCT02421939 COMPLETED
Leukemia, Acute Myeloid (AML)
Astellas Pharma Global Development, Inc.
2015-10-20 PHASE3
NCT02597387 UNKNOWN
Relapsed DLBCL and PT/NKCLs
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2015-08 PHASE2
NCT02462265 SUSPENDED
Acute Myeloid Leukemia; Lymphoid Leukemia
Oshadi Drug Administration
2017-01 PHASE2
NCT01830777 COMPLETED
Acute Myelogenous Leukemia
Massachusetts General Hospital
2013-05 PHASE1
NCT02686593 COMPLETED
Acute Myeloid Leukemia
The University of Hong Kong
2016-02-01 PHASE2
NCT02518750 TERMINATED
Acute Lymphoblastic Leukemia; Lymphoma, Non-Hodgkin's; Leukemia, T-Cell; Leukemia, B-Cell
St. Jude Children's Research Hospital
2016-11-23 PHASE2
NCT02044796 COMPLETED
Acute Biphenotypic Leukemia; de Novo Myelodysplastic Syndrome; Previously Treated Myelodysplastic Syndrome; Recurrent Adult Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia
Fred Hutchinson Cancer Center
2014-01-23 PHASE1; PHASE2
NCT02299518 COMPLETED
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Recurrent Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia
Alice Mims
2015-05-18 PHASE1
NCT01828489 UNKNOWN
Pediatric Acute Myeloblastic Leukemia
Vastra Gotaland Region
2013-03 PHASE3
NCT02626338 COMPLETED
Relapsed/Refractory Acute Myeloid Leukemia (AML)
Arog Pharmaceuticals, Inc.
2016-02 PHASE1; PHASE2
NCT02573363 COMPLETED
Acute Myeloid Leukemia
University of Chicago
2015-10-07 PHASE1
NCT02596373 UNKNOWN
Advanced Recurrent or Metastatic Breast Cancer
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2015-06 PHASE2
NCT02306291 COMPLETED
Leukemia, Myeloid, Acute
GlycoMimetics Incorporated
2015-03 PHASE1; PHASE2
NCT02597153 TERMINATED
Relapsed Cutaneous T Cell Lymphom
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2015-10 PHASE2
NCT00254410 COMPLETED
Chronic Lymphocytic Leukemia
M.D. Anderson Cancer Center
2005-03-14 PHASE2
NCT00577993 COMPLETED
Lymphoma
M.D. Anderson Cancer Center
1998-03-16 PHASE3
NCT00004124 COMPLETED
Prostate Cancer
SWOG Cancer Research Network
1999-10-15 PHASE3
NCT01801046 TERMINATED
Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Childhood Acute Erythroleukemia (M6); Childhood Acute Megakaryocytic Leukemia (M7); Childhood Acute Monoblastic Leukemia (M5a); Childhood Acute Monocytic Leukemia (M5b); Childhood Acute Myeloblastic Leukemia With Maturation (M2); Childhood Acute Myeloblastic Leukemia Without Maturation (M1); Childhood Acute Myeloid Leukemia in Remission; Childhood Acute Myelomonocytic Leukemia (M4); Recurrent Adult Acute Myeloid Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia; Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
University of Southern California
2013-03-06 PHASE1
NCT02856685 UNKNOWN
Non-Hodgkin's Lymphoma
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2016-08 PHASE1; PHASE2
NCT02535806 TERMINATED
Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
Children's Mercy Hospital Kansas City
2015-07 PHASE2
NCT02070458 COMPLETED
Recurrent Adult Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
Case Comprehensive Cancer Center
2014-10-08 PHASE1
NCT02419755 TERMINATED
Mixed Lineage Acute Leukemia; Acute Myeloid Leukemia; Acute Lymphoid Leukemia
St. Jude Children's Research Hospital
2015-04-14 PHASE2
NCT02595242 WITHDRAWN
Diffuse Large B Cell Lymphoma
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2015-06 PHASE1
NCT02198482 TERMINATED
Acute Myeloid Leukemia (AML); High-risk Myelodysplastic Syndrome (MDS)
University of Ulm
2016-02 PHASE2
NCT02631252 TERMINATED
Leukemia, Acute Myelogenous
Alison Sehgal, MD, MS
2016-08-18 PHASE1
NCT01729845 COMPLETED
Previously Treated Myelodysplastic Syndrome; Recurrent Adult Acute Myeloid Leukemia
Fred Hutchinson Cancer Center
2012-12-20 PHASE1; PHASE2
NCT00186875 COMPLETED
Acute Lymphoblastic Leukemia; Lymphoma, Lymphoblastic
St. Jude Children's Research Hospital
2003-11 PHASE2
NCT01594918 COMPLETED
Metastatic Castration-resistant Prostate Cancer
Rahul Aggarwal
2012-06 PHASE1
NCT01564784 COMPLETED
Acute Lymphoblastic Leukemia
Pfizer
2012-08-02 PHASE3
NCT01768897 COMPLETED
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Recurrent Adult Acute Myeloid Leukemia
Wake Forest University Health Sciences
2013-01 PHASE1
NCT00901927 TERMINATED
Follicular Lymphoma
M.D. Anderson Cancer Center
2009-05 PHASE2
NCT01681537 COMPLETED
Acute Myelogenous Leukemia
Massachusetts General Hospital
2012-09 PHASE1
NCT01578343 TERMINATED
Mantle Cell Lymphoma
Samsung Medical Center
2012-06 PHASE2
NCT02131688 UNKNOWN
Malignant Lymphoma
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2013-05 PHASE1
NCT01483690 TERMINATED
Acute Lymphoblastic Leukemia; Precursor B-Cell Lymphoblastic Leukemia; Precursor T-Cell Lymphoblastic Leukemia
Therapeutic Advances in Childhood Leukemia Consortium
2011-12 PHASE1; PHASE2
NCT00866918 COMPLETED
Childhood Acute Promyelocytic Leukemia With PML-RARA; Myeloid Neoplasm
Children's Oncology Group
2009-03-09 PHASE3
NCT00059631 COMPLETED
Prostate Cancer
M.D. Anderson Cancer Center
2003-03-20 PHASE1
NCT01904643 TERMINATED
Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia
Stanford University
2014-02 PHASE1
NCT01403415 COMPLETED
Childhood B Acute Lymphoblastic Leukemia; Childhood T Acute Lymphoblastic Leukemia; Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Lymphoblastic Lymphoma
National Cancer Institute (NCI)
2011-09 PHASE1
NCT01627938 UNKNOWN
Multiple Sclerosis
PD Dr. Andrew Chan
2012-04 PHASE2
NCT01222143 TERMINATED
Acute Myeloid Leukemia
University Health Network, Toronto
2010-10 PHASE1; PHASE2
NCT01260714 TERMINATED
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia; Adult Acute Monoblastic Leukemia; Adult Acute Monocytic Leukemia; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With Maturation; Adult Acute Myeloid Leukemia With Minimal Differentiation; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1; Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL; Adult Acute Myeloid Leukemia Without Maturation; Adult Acute Myelomonocytic Leukemia; Adult Erythroleukemia; Adult Pure Erythroid Leukemia; Alkylating Agent-Related Acute Myeloid Leukemia; Recurrent Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia
National Cancer Institute (NCI)
2010-12 PHASE1
NCT01523860 COMPLETED
Follicular Lymphoma
Fondazione Italiana Linfomi - ETS
2009-06 PHASE2
NCT01550185 TERMINATED
Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia
Roswell Park Cancer Institute
2012-05 PHASE1
NCT02021825 UNKNOWN
Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorders
Xuanwu Hospital, Beijing
2009-03 PHASE4
NCT01522443 TERMINATED
Prostate Cancer; Castration Resistant Prostate Cancer; Pain; Prostatic Neoplasms
Exelixis
2012-03 PHASE3
NCT00634244 COMPLETED
Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia
National Cancer Institute (NCI)
2008-10 PHASE2
NCT01144403 TERMINATED
Diffuse Large B-Cell Lymphoma
Hoffmann-La Roche
2010-06 PHASE2
NCT01186640 COMPLETED
T-cell-prolymphocytic Leukemia
German CLL Study Group
2010-06 PHASE2
NCT01349972 COMPLETED
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia
National Cancer Institute (NCI)
2011-04 PHASE2
NCT01127009 COMPLETED
Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia
Case Comprehensive Cancer Center
2010-07 PHASE1
NCT00546377 COMPLETED
Leukemia; Lymphoma
Memorial Sloan Kettering Cancer Center
2005-07 PHASE1; PHASE2
NCT01004497 COMPLETED
Acute Lymphoblastic Leukemia
The Catholic University of Korea
2010-03 PHASE2
NCT01174888 COMPLETED
Acute Myeloid Leukemia; Acute Myeloid Leukemia With Multilineage Dysplasia Following; Myelodysplastic Syndrome; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Recurrent Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia
Alison Walker
2010-08 PHASE1
NCT00940524 COMPLETED
Leukemia; Acute Lymphoblastic Leukemia
Memorial Sloan Kettering Cancer Center
2009-07 PHASE1
NCT00458848 COMPLETED
Leukemia
Gruppo Italiano Malattie EMatologiche dell'Adulto
2004-10 PHASE2
NCT00317408 UNKNOWN
Lymphoma
European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma
2004-04
NCT01133158 COMPLETED
Non-Hodgkin's Lymphoma
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
2009-07 PHASE2
NCT00372593 COMPLETED
Leukemia
Children's Oncology Group
2006-08 PHASE3
NCT02043756 COMPLETED
Neoplasms
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2011-08 PHASE1
NCT01249430 COMPLETED
Recurrent Adult Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
National Cancer Institute (NCI)
2011-01-20 PHASE1
NCT01154439 COMPLETED
Leukemia
Gruppo Italiano Malattie EMatologiche dell'Adulto
2010-10 PHASE1
NCT00410423 COMPLETED
Relapsed Acute Leukemia; Refractory Acute Leukemia
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
2006-01 PHASE1; PHASE2
NCT01701375 TERMINATED
Relapsed Acute Leukemia; Refractory Acute Leukemia; High-Risk Myelodysplasia
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2012-09 PHASE1
NCT00510887 TERMINATED
Lymphoma, Follicular
Duke University
2007-01 PHASE2
NCT00853008 COMPLETED
Acute Lymphoblastic Leukemia
PETHEMA Foundation
2003-01 PHASE4
NCT00906945 COMPLETED
Leukemia, Myeloid, Acute
Washington University School of Medicine
2011-02 PHASE1; PHASE2
NCT00180128 UNKNOWN
Leukemia, Promyelocytic, Acute
Technische Universität Dresden
2000-01 PHASE4
NCT01204710 COMPLETED
Prostate Cancer
Eli Lilly and Company
2010-10 PHASE2
NCT01382147 COMPLETED
Acute Myeloid Leukemia
Prof. Dr. Wolfgang Hiddemann
2009-07-01 PHASE3
NCT00436839 COMPLETED
Prostatic Neoplasms
Sanofi
2007-01 PHASE3
NCT00408278 COMPLETED
Acute Promyelocytic Leukemia
PETHEMA Foundation
2005-07 PHASE4
NCT01342887 TERMINATED
Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia
Fred Hutchinson Cancer Center
2011-04 PHASE1; PHASE2
NCT01055483 COMPLETED
Acute Myeloid Leukemia
Novartis Pharmaceuticals
2009-09 PHASE1
NCT01184898 COMPLETED
AML
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
2010-07
NCT01214317 COMPLETED
Multiple Sclerosis
Isfahan University of Medical Sciences
2010-01
NCT00002766 COMPLETED
Leukemia; Lymphoma
Memorial Sloan Kettering Cancer Center
1996-03 PHASE3
NCT00683475 COMPLETED
Prostate Cancer
Eli Lilly and Company
2008-08 PHASE2
NCT00499018 UNKNOWN
Diffuse Large B-Cell Lymphoma; IPI≥2
Fondazione Italiana Linfomi - ETS
2006-01 PHASE3
NCT00840684 COMPLETED
Leukemia
Institut Paoli-Calmettes
2009-01 PHASE1; PHASE2
NCT00627354 COMPLETED
Prostate Cancer
Groupe D'Etude des Tumeurs Uro-Genitales
2006-09 PHASE2
NCT00660036 TERMINATED
Acute Myeloid Leukemia
University of Pittsburgh
2008-09 PHASE1
NCT00562965 TERMINATED
Lymphoma, Follicular
Pfizer
2007-11 PHASE3
NCT00774046 COMPLETED
Myelodysplastic Syndrome; Acute Myeloid Leukemia
University of Chicago
2002-12 PHASE2
NCT00882076 TERMINATED
Leukemia
Milton S. Hershey Medical Center
2009-03 PHASE1
NCT00661492 COMPLETED
Androgen-independent Prostate Cancer
US Oncology Research
2008-05 PHASE2
NCT00470197 COMPLETED
Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Malignant Neoplasm; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia
National Cancer Institute (NCI)
2007-04 PHASE1
NCT00770848 COMPLETED
Cancer; Castrate-Resistant Prostate Cancer; Mestastatic Prostate Cancer; Prostate Cancer
Amgen
2008-11 PHASE1; PHASE2
NCT00079105 COMPLETED
Lymphoma
Newcastle-upon-Tyne Hospitals NHS Trust
2004-01 PHASE2
NCT00744081 COMPLETED
AML
Goethe University
2004-07 PHASE2
NCT00109837 COMPLETED
Leukemia
SWOG Cancer Research Network
2005-04 PHASE2
NCT00331344 COMPLETED
Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IV Prostate Cancer
National Cancer Institute (NCI)
2006-04 PHASE1; PHASE2
NCT00795002 COMPLETED
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia
National Cancer Institute (NCI)
2008-11 PHASE2
NCT00327340 COMPLETED
Prostate Cancer
Achieve Life Sciences
2006-07 PHASE2
NCT00268242 TERMINATED
Leukemia
The Cleveland Clinic
2006-01 PHASE2
NCT00180167 COMPLETED
Leukemia, Nonlymphocytic, Acute
Technische Universität Dresden
2005-01 PHASE4
NCT01027923 TERMINATED
Leukemia, Myeloid, Acute
Washington University School of Medicine
2010-05 PHASE1
NCT00609739 TERMINATED
Leukemia
Masonic Cancer Center, University of Minnesota
1999-06 PHASE1; PHASE2
NCT00512252 COMPLETED
Leukemia, Myeloid, Acute
Washington University School of Medicine
2007-07 PHASE1; PHASE2
NCT00017563 COMPLETED
Prostate Cancer
OHSU Knight Cancer Institute
2000-09 PHASE2
NCT00002517 COMPLETED
Leukemia; Myelodysplastic Syndromes
European Organisation for Research and Treatment of Cancer - EORTC
1993-03 PHASE3
NCT00780104 COMPLETED
Myeloid Leukemias; AML; Leukemia; CML
Abramson Cancer Center at Penn Medicine
2007-07 PHASE1
NCT00967057 COMPLETED
Leukemia
Children's Cancer and Leukaemia Group
2002-10 PHASE3
NCT00208975 TERMINATED
Lymphoma
Emory University
2002-07 PHASE2
NCT01142466 COMPLETED
Multiple Sclerosis, Relapsing-Remitting
Merck KGaA, Darmstadt, Germany
2005-12 PHASE4
NCT00842595 COMPLETED
Diffuse Large B-Cell Lymphoma
French Innovative Leukemia Organisation
2003-12 PHASE2
NCT00180102 COMPLETED
Leukemia, Nonlymphocytic, Acute
Technische Universität Dresden
2003-12 PHASE4
NCT00477087 TERMINATED
Prostatic Neoplasms
Stanford University
2006-07 PHASE2
NCT01126814 COMPLETED
Leukemia
University Health Network, Toronto
2004-07 PHASE1; PHASE2
NCT00417079 COMPLETED
Neoplasms; Prostatic Neoplasms
Sanofi
2007-01 PHASE3
NCT00107354 COMPLETED
Leukemia; Myelodysplastic Syndromes
Fred Hutchinson Cancer Center
1998-12 PHASE1
NCT01560117 COMPLETED
Follicular T-NHL Lymphoma; Rituximab Maintenance
Arbeitsgemeinschaft medikamentoese Tumortherapie
2004-01 PHASE2
NCT00151255 COMPLETED
Acute Myeloid Leukemia
University of Ulm
2004-06 PHASE3
NCT00003650 COMPLETED
Lymphoma
UNICANCER
1997-02 PHASE3
NCT00385827 TERMINATED
Cancer, Prostate
Centocor, Inc.
2006-11 PHASE2
NCT00447473 TERMINATED
Prostatic Neoplasms
The Methodist Hospital Research Institute
2006-07 PHASE2
NCT00407966 COMPLETED
Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia
National Cancer Institute (NCI)
2006-10 PHASE2
NCT00136084 COMPLETED
Leukemia, Myelocytic, Acute
St. Jude Children's Research Hospital
2002-08 PHASE3
NCT00193479 COMPLETED
Non-Hodgkins Lymphoma
SCRI Development Innovations, LLC
2003-04 PHASE2
NCT00452387 TERMINATED
Metastatic Prostate Cancer
Accelerated Community Oncology Research Network
2007-05 PHASE2
NCT00003728 UNKNOWN
Leukemia; Lymphoma
European Organisation for Research and Treatment of Cancer - EORTC
1998-12 PHASE3
NCT00052299 COMPLETED
Leukemia
European Organisation for Research and Treatment of Cancer - EORTC
2002-09 PHASE3
NCT00274963 COMPLETED
Chronic Lymphocytic Leukemia
German CLL Study Group
2004-10 PHASE2
NCT00058084 COMPLETED
Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IV Prostate Cancer
National Cancer Institute (NCI)
2003-03 PHASE2
NCT00146159 TERMINATED
Secondary Progressive Multiple Sclerosis
Wyeth is now a wholly owned subsidiary of Pfizer
2005-03 PHASE3
NCT00004071 COMPLETED
Prostate Cancer
Pfizer
1999-08 PHASE2; PHASE3
NCT00143975 COMPLETED
Leukemia, Myeloid, Acute
University of Ulm
2004-06 PHASE2
NCT00274807 COMPLETED
Leukemia
The Cleveland Clinic
2001-06 PHASE2
NCT00002565 COMPLETED
Lymphoma
M.D. Anderson Cancer Center
1994-05-25 PHASE3
NCT00005985 COMPLETED
Lymphoma
Masonic Cancer Center, University of Minnesota
2000-08 PHASE2
NCT00278213 COMPLETED
Prolymphocytic Leukemia
German CLL Study Group
2002-09 PHASE2
NCT00656084 COMPLETED
Relapsed or Refractory Mantle Cell Lymphoma (MCL)
US Oncology Research
2004-12 PHASE2
NCT00119730 COMPLETED
Mantle Cell Lymphoma
Dana-Farber Cancer Institute
2005-02 PHASE2
NCT00169208 COMPLETED
Follicular Lymphoma
Lymphoma Study Association
2001-04 PHASE2
NCT00183989 TERMINATED
Mantle Cell Lymphoma
University of Southern California
2000-08 PHASE2
NCT00016016 COMPLETED
Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Adult Acute Myeloid Leukemia
National Cancer Institute (NCI)
2001-02 PHASE1; PHASE2
NCT00185445 COMPLETED
Non Hodgkin Lymphoma
Genzyme, a Sanofi Company
2004-06 PHASE2
NCT00028899 COMPLETED
Leukemia; Myelodysplastic Syndromes
Children's Oncology Group
2002-07 PHASE1
NCT00070174 COMPLETED
Leukemia
Children's Oncology Group
2003-12 PHASE2
NCT00182741 COMPLETED
Prostate Cancer
OHSU Knight Cancer Institute
2004-09 PHASE2
NCT00183924 COMPLETED
Prostate Adenocarcinoma
University of Southern California
2001-03 PHASE2
NCT00004001 COMPLETED
Prostate Cancer
SWOG Cancer Research Network
1999-10 PHASE3
NCT00002912 COMPLETED
Leukemia
National Cancer Institute (NCI)
1997-01 PHASE1
NCT00124566 COMPLETED
Prostate Cancer
Eisai Inc.
2004-06 PHASE2
NCT00047021 COMPLETED
Leukemia; Lymphoma
Case Comprehensive Cancer Center
2001-11 PHASE2
NCT00526305 COMPLETED
Acute Lymphoblastic Leukemia
PETHEMA Foundation
2000-01 PHASE4
NCT00005802 COMPLETED
Leukemia
Fred Hutchinson Cancer Center
1999-06 PHASE1; PHASE2
NCT00203073 COMPLETED
Relapsing Remitting Multiple Sclerosis
Teva Branded Pharmaceutical Products R&D, Inc.
2003-06 PHASE2
NCT00005847 COMPLETED
Prostate Cancer
Eastern Cooperative Oncology Group
2001-04-05 PHASE2
NCT00002598 COMPLETED
Leukemia
Memorial Sloan Kettering Cancer Center
1994-06 PHASE2
NCT00003407 WITHDRAWN
Drug/Agent Toxicity by Tissue/Organ; Leukemia; Myelodysplastic Syndromes; Neutropenia
Rush University Medical Center
2001-02-13 PHASE2
NCT00003215 COMPLETED
Lymphoma
Swiss Cancer Institute
1997-04 PHASE3
NCT00002700 COMPLETED
Leukemia; Lymphoma
European Organisation for Research and Treatment of Cancer - EORTC
1995-08 PHASE3
NCT00002835 COMPLETED
Lymphoma
M.D. Anderson Cancer Center
1995-10-30 PHASE3
NCT00053131 COMPLETED
Leukemia
Roswell Park Cancer Institute
1999-01 PHASE2
NCT00416910 TERMINATED
Chronic Lymphocytic Leukemia
German CLL Study Group
1999-07 PHASE3
NCT00005987 TERMINATED
Multiple Myeloma and Plasma Cell Neoplasm
Masonic Cancer Center, University of Minnesota
2000-08 PHASE2
NCT00015951 COMPLETED
Leukemia; Myelodysplastic Syndromes
University of Maryland, Baltimore
2001-04 PHASE2
NCT00005998 WITHDRAWN
Lymphoma
Masonic Cancer Center, University of Minnesota
2000-01 PHASE2
NCT00003232 COMPLETED
Pain; Prostate Cancer; Quality of Life
NCIC Clinical Trials Group
1997-11-24 PHASE3
NCT00004197 COMPLETED
Lymphoma
University of Nebraska
1999-06-25 PHASE2
NCT00006122 COMPLETED
Leukemia
European Organisation for Research and Treatment of Cancer - EORTC
2000-06 PHASE2
NCT00002719 COMPLETED
Leukemia; Neutropenia
European Organisation for Research and Treatment of Cancer - EORTC
1995-12 PHASE3
NCT00003080 COMPLETED
Ovarian Cancer
Fred Hutchinson Cancer Center
1996-09 PHASE1
NCT00002805 COMPLETED
Leukemia
Children's Oncology Group
1997-08 PHASE2
NCT00003032 COMPLETED
Breast Cancer
NCIC Clinical Trials Group
1997-04-25 PHASE3
NCT00003297 COMPLETED
Ovarian Cancer
Georgetown University
1997-12 PHASE1; PHASE2
NCT00003343 COMPLETED
Prostate Cancer
Pfizer
1998-03 PHASE3
NCT00003957 COMPLETED
Lymphoma
Fox Chase Cancer Center
1998-12 PHASE2
NCT00003003 COMPLETED
Leukemia
Dartmouth-Hitchcock Medical Center
1996-09 PHASE1
NCT00002674 COMPLETED
Leukemia
Fred Hutchinson Cancer Center
1994-10 PHASE2
NCT00002819 TERMINATED
Ovarian Cancer
Gynecologic Oncology Group
1996-11 PHASE3
NCT00003405 WITHDRAWN
Leukemia
Rush University Medical Center
1998-04 PHASE2
NCT00199069 COMPLETED
Adult Acute Lymphocytic Leukemia
Goethe University
1993-04 PHASE4
NCT00002688 UNKNOWN
Leukemia
University Medical Center Groningen
1995-02 PHASE2
NCT00002905 UNKNOWN
Lymphoma
Centro di Riferimento Oncologico - Aviano
1995-06 PHASE2
NCT00337246 COMPLETED
Leukemia
Cancer Research UK
2005-07 PHASE2
NCT00048659 TERMINATED
Hormone-Refractory Prostate Cancer; Prostatic Neoplasms
Astellas Pharma Inc
PHASE2
NCT00005823 COMPLETED
Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms
Leukemia Research Fund
1998-12 PHASE3
NCT00006250 UNKNOWN
Lymphoma
Lymphoma Trials Office
2000-05 PHASE3
NCT00002003 COMPLETED
Lymphoma, Non-Hodgkin; HIV Infections
Lederle Laboratories
PHASE2
NCT00002701 UNKNOWN
Leukemia
European Organisation for Research and Treatment of Cancer - EORTC
1995-10 PHASE3
NCT00002259 COMPLETED
Sarcoma, Kaposi; HIV Infections
Lederle Laboratories
PHASE2
NCT00003183 UNKNOWN
Prostate Cancer
Hope Cancer Institute, Inc.
1997-03 PHASE1; PHASE2
NCT00006114 UNKNOWN
Prostate Cancer
GERCOR - Multidisciplinary Oncology Cooperative Group
1999-05 PHASE2
NCT00006045 UNKNOWN
Leukemia
Facet Biotech
2000-03 PHASE3
NCT00003436 COMPLETED
Leukemia; Myelodysplastic Syndromes
Medical Research Council
1998-07 PHASE3
NCT00556127 COMPLETED
Diffuse Large B-Cell Lymphoma; POOR PROGNOSIS
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
2002-06 PHASE2
NCT00859001 COMPLETED
Follicular Lymphoma
University of Bologna
PHASE2
NCT00024492 COMPLETED
Tumors
INSYS Therapeutics Inc
2001-08 PHASE1
NCT00002531 UNKNOWN
Leukemia
Johann Wolfgang Goethe University Hospital
1993-01 PHASE2
NCT00304291 COMPLETED
Neuromyelitis Optica; Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System
State University of New York at Buffalo
2001-08 PHASE4
NCT00002474 COMPLETED
Ovarian Cancer
Loyola University
1991-02 PHASE2
NCT00003858 WITHDRAWN
Prostate Cancer
Alliance for Clinical Trials in Oncology
PHASE2
NCT00002549 UNKNOWN
Leukemia
European Organisation for Research and Treatment of Cancer - EORTC
1993-11 PHASE3
NCT00002576 COMPLETED
Lymphoma
Cancer Research Campaign Clinical Trials Centre
1992-11 PHASE3
NCT00032149 UNKNOWN
Lymphoma
Lymphoma Trials Office
2001-10 PHASE1; PHASE2
NCT00003602 UNKNOWN
Leukemia; Myelodysplastic Syndromes
Riverside Haematology Group
1998-03 PHASE3
NCT00005867 COMPLETED
Lymphoma
Lymphoma Trials Office
1998-01 PHASE3
NCT00219908 TERMINATED
Relapsing-Remitting Multiple Sclerosis
Rennes University Hospital
1999-07 PHASE2
NCT00002544 COMPLETED
Breast Cancer
Arbeitsgemeinschaft fur Internistische Onkologie
1993-05 PHASE3
NCT00002658 UNKNOWN
Leukemia; Neutropenia
Medical Research Council
1994-01 PHASE3
NCT00004237 COMPLETED
Breast Cancer
Royal Marsden NHS Foundation Trust
1998-10 PHASE2
NCT00002498 UNKNOWN
Breast Cancer
Leiden University Medical Center
1992-07 PHASE2
NCT00003893 COMPLETED
Breast Cancer
University Hospital Birmingham
1998-07 PHASE3
NCT00003068 COMPLETED
Breast Cancer; Drug/Agent Toxicity by Tissue/Organ
University of Arizona
1997-06 PHASE2
NCT00003633 UNKNOWN
Prostate Cancer
Herbert Irving Comprehensive Cancer Center
1998-08 PHASE1
NCT00010075 UNKNOWN
Breast Cancer
GERCOR - Multidisciplinary Oncology Cooperative Group
2000-01 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-29)

Check the Mitoxantrone Dihydrochloride (NSC 301739) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mitoxantrone intercalates into deoxyribonucleic acid through hydrogen bonding and potently inhibits topoisomerase II, thereby disrupting enzyme-mediated DNA uncoiling and generating strand breaks. This inhibition halts nucleic acid synthesis and induces cellular apoptosis, ultimately resulting in the suppression of tumor growth in clinical contexts such as acute myeloid leukemia, diffuse large B-cell lymphoma, and breast cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.