Daunorubicin Hydrochloride (Daunomycin) Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Daunorubicin Hydrochloride has been evaluated in numerous clinical trials spanning Early Phase 1 through Phase 4, primarily targeting hematologic malignancies such as acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes, and chronic myelomonocytic leukemia across pediatric and adult populations. Sponsored by academic medical centers, government organizations like the National Cancer Institute, clinical networks, and pharmaceutical companies, these investigations encompass completed, active recruiting, and terminated protocols. Ongoing efforts aim to optimize efficacy and overcome resistance through novel approaches, including targeted dosing strategies in relapsed pediatric leukemia and liposomal formulations for high-risk myelodysplastic syndromes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07072585	NOT_YET_RECRUITING	Stage II T Lymphoblastic Leukemia/Lymphoma; Stage III T Lymphoblastic Leukemia/Lymphoma; Stage IV T Lymphoblastic Leukemia/Lymphoma; T Acute Lymphoblastic Leukemia; T Lymphoblastic Lymphoma	Children's Oncology Group	2026-08-28	PHASE2; PHASE3
NCT06947967	RECRUITING	Lymphoma, T-Cell, Peripheral	Chipscreen Biosciences, Ltd.	2025-08-12	PHASE3
NCT03013998	RECRUITING	Previously Untreated Relapsed Refractory Acute Myeloid Leukemia	Beat AML, LLC	2016-11	PHASE2; PHASE3
NCT07007312	RECRUITING	Acute Myeloid Leukemia (AML)	Kura Oncology, Inc.	2025-09-26	PHASE3
NCT07223814	RECRUITING	Acute Myeloid Leukemia	Stichting Hemato-Oncologie voor Volwassenen Nederland	2026-03-01	PHASE3
NCT07078591	RECRUITING	Acute Myeloid Leukemia	Beijing 302 Hospital	2025-06-20	PHASE2
NCT05735184	RECRUITING	Acute Myeloid Leukemia; Mixed Lineage Leukemia Gene Mutation; Refractory AML; AML With Mutated NPM1; Acute Myeloid Leukemia Recurrent; Acute Myeloid Leukemia, in Relapse; NPM1 Mutation; KMT2Ar; Myeloid Sarcoma; Nucleophosmin 1-mutated Acute Myeloid Leukemia	Kura Oncology, Inc.	2023-07-18	PHASE1
NCT07651176	ENROLLING_BY_INVITATION	Acute Myeloid Leukemia; Lisaftoclax	First Affiliated Hospital of Zhejiang University	2026-03-01	PHASE2; PHASE3
NCT04293562	RECRUITING	Acute Myeloid Leukemia	Children's Oncology Group	2020-07-21	PHASE3
NCT06918431	RECRUITING	B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative; Lymphoblastic Lymphoma	City of Hope Medical Center	2025-10-10	PHASE2
NCT05342584	RECRUITING	Acute Myeloid Leukemia; Myelodysplastic Syndromes	Montefiore Medical Center	2022-05-25	PHASE1
NCT07588698	NOT_YET_RECRUITING	Non-Hodgkin's B-cell Lymphoma; Lymphoma Non-Hodgkin; Diffuse Large B-Cell Lymphoma (DLBCL)	Carrie Ho, MD	2026-09-15	PHASE2
NCT03643276	RECRUITING	Acute Lymphoblastic Leukemia, Pediatric	Martin Schrappe	2018-07-15	PHASE3
NCT06262438	RECRUITING	Acute Myeloid Leukemia in Children	Princess Maxima Center for Pediatric Oncology	2024-02-06	PHASE2
NCT05886049	RECRUITING	Acute Myeloid Leukemia; Acute Myeloid Leukemia With KMT2A Rearrangement; Acute Myeloid Leukemia With NPM1 Mutation; Secondary Acute Myeloid Leukemia	National Cancer Institute (NCI)	2024-06-20	PHASE1
NCT04128748	ACTIVE_NOT_RECRUITING	Acute Myeloid Leukemia; Blasts More Than 10 Percent of Bone Marrow Nucleated Cells; High Risk Myelodysplastic Syndrome; Recurrent Acute Myeloid Leukemia; Recurrent Myelodysplastic Syndrome; Refractory Acute Myeloid Leukemia; Refractory Myelodysplastic Syndrome	M.D. Anderson Cancer Center	2020-05-27	PHASE1; PHASE2
NCT06744556	ACTIVE_NOT_RECRUITING	AML	Institute of Hematology & Blood Diseases Hospital, China	2025-01-21	PHASE2
NCT07255872	NOT_YET_RECRUITING	Acute Myeloid Leukemia	Sichuan Baili Pharmaceutical Co., Ltd.	2026-03	PHASE2; PHASE3
NCT03897127	ACTIVE_NOT_RECRUITING	Acute Myeloid Leukemia	University of Ulm	2019-09-04	PHASE3
NCT04385290	RECRUITING	Acute Myeloid Leukemia	Technische Universität Dresden	2020-09-04	PHASE1; PHASE2
NCT06313437	RECRUITING	Acute Myeloid Leukemia; AML, Adult; AML With Gene Mutations; AML; Leukemia	Richard Stone, MD	2024-12-06	PHASE1
NCT04801797	ACTIVE_NOT_RECRUITING	Acute Myeloid Leukemia	Massachusetts General Hospital	2021-05-20	PHASE2
NCT05681260	RECRUITING	T-cell Lymphoblastic Lymphoma	Children's Cancer Group, China	2023-02-06	PHASE3
NCT07561892	RECRUITING	Acute Myeloid Leukemia; Newly Diagnosed; Chemotherapy Effect	Fujian Medical University Union Hospital	2022-04-01	PHASE4
NCT06345365	RECRUITING	Acute Myeloid Leukaemia	Zhongnan Hospital	2024-01-18	PHASE3
NCT04049539	RECRUITING	Blasts More Than 5 Percent of Bone Marrow Nucleated Cells; Persistent Disease; Refractory Acute Myeloid Leukemia	Ohio State University Comprehensive Cancer Center	2021-01-29	PHASE1; PHASE2
NCT07156435	RECRUITING	Relapsed Pediatric AML; Refractory Pediatric AML	Princess Maxima Center for Pediatric Oncology	2020-11-06	PHASE1
NCT05453903	ACTIVE_NOT_RECRUITING	Leukemia, Myeloid, Acute	Janssen Research & Development, LLC	2022-10-04	PHASE1
NCT03117751	ACTIVE_NOT_RECRUITING	Acute Lymphoblastic Leukemia; Acute Lymphoblastic Lymphoma	St. Jude Children's Research Hospital	2017-03-29	PHASE2; PHASE3
NCT06210750	WITHDRAWN	T Acute Lymphoblastic Leukemia; T Lymphoblastic Lymphoma	National Cancer Institute (NCI)	2024-08-09	PHASE2
NCT05554419	NOT_YET_RECRUITING	Acute Myeloid Leukemia; Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Acute Myeloid Leukemia Arising From Previous Myeloproliferative Neoplasm; Acute Myeloid Leukemia Post Cytotoxic Therapy; Secondary Acute Myeloid Leukemia	National Cancer Institute (NCI)	2026-07-01	PHASE2
NCT03672539	COMPLETED	Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia; High Risk Myelodysplastic Syndrome; Myelodysplastic Syndrome; Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia	M.D. Anderson Cancer Center	2018-11-07	PHASE2
NCT05939180	RECRUITING	Acute Myeloid Leukemia	The First Affiliated Hospital of Soochow University	2024-04-01	PHASE2; PHASE3
NCT04061239	RECRUITING	MDS; AML	GWT-TUD GmbH	2019-08-19	PHASE2
NCT06697327	ENROLLING_BY_INVITATION	Leukemia, Myeloid, Acute; Acute Myeloid Leukemia	Anhui Medical University	2025-02-01
NCT02416388	RECRUITING	Acute Myeloid Leukemia (AML)	University Hospital, Angers	2015-01	PHASE2; PHASE3
NCT04269213	COMPLETED	Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Acute Myeloid Leukemia With Myelodysplasia-Related Changes; Secondary Acute Myeloid Leukemia; Therapy-Related Acute Myeloid Leukemia	Roswell Park Cancer Institute	2021-07-29	PHASE2
NCT03878199	TERMINATED	Essential Thrombocythemia; Myelofibrosis; Myeloproliferative Neoplasm; Polycythemia Vera; Secondary Acute Myeloid Leukemia	Ohio State University Comprehensive Cancer Center	2019-02-20	PHASE1; PHASE2
NCT03825796	ACTIVE_NOT_RECRUITING	Recurrent Acute Myeloid Leukemia	Jonsson Comprehensive Cancer Center	2019-04-12	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
NCT03026842	UNKNOWN	Acute Myeloid Leukemia	The First Hospital of Jilin University	2017-01	PHASE4
NCT03904251	TERMINATED	Acute Myelogenous Leukemia	Jonsson Comprehensive Cancer Center	2019-07-18	PHASE1
NCT03878927	TERMINATED	Acute Myeloid Leukemia	Weill Medical College of Cornell University	2019-08-23	PHASE1
NCT04562792	COMPLETED	Relapsed Pediatric ALL; Relapsed Pediatric AML; Refractory Acute Myeloid Leukemia; Refractory Acute Lymphoblastic Leukemia	Children's Mercy Hospital Kansas City	2020-05-08	PHASE2
NCT02140242	COMPLETED	Leukemia, Myelocytic, Acute	Technische Universität Dresden	2014-04-16	PHASE3
NCT02523976	COMPLETED	Acute,Leukemia, Lymphoid	Institute of Hematology & Blood Diseases Hospital, China	2015-08-01	PHASE2
NCT03988205	TERMINATED	Leukemia, Myeloid, Acute	Medical College of Wisconsin	2019-08-28	PHASE4
NCT04109690	WITHDRAWN	MDS	Yale University	2019-12-30	PHASE1; PHASE2
NCT02236013	COMPLETED	Acute Myeloid Leukemia	Astellas Pharma Global Development, Inc.	2015-01-07	PHASE1
NCT03379727	COMPLETED	Acute Myeloid Leukemia	Novartis Pharmaceuticals	2018-02-13	PHASE3
NCT04920500	UNKNOWN	Acute Myeloid Leukemia	CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	2020-09-04
NCT03555955	COMPLETED	Hematologic Malignancy; Acute Myeloid Leukemia; Acute Lymphocytic Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndromes	Jazz Pharmaceuticals	2018-11-20	PHASE1
NCT03586999	COMPLETED	Peripheral T Cell Lymphoma	University of Colorado, Denver	2018-11-07	PHASE1; PHASE2
NCT02085408	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	ECOG-ACRIN Cancer Research Group	2011-02-04	PHASE3
NCT02038777	COMPLETED	Acute Myeloid Leukemia	Pfizer	2014-03-25	PHASE1
NCT03568994	COMPLETED	Acute Myeloid Leukemia	Baylor College of Medicine	2018-07-10	EARLY_PHASE1
NCT00549848	COMPLETED	Acute Lymphoblastic Leukemia	St. Jude Children's Research Hospital	2007-10-29	PHASE3
NCT03850535	TERMINATED	Acute Myeloid Leukemia	Hoffmann-La Roche	2019-03-25	PHASE1; PHASE2
NCT03416179	COMPLETED	Leukemia, Myeloid, Acute	Pfizer	2018-04-20	PHASE3
NCT02029950	COMPLETED	Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia-2; High Risk Myelodysplastic Syndrome; Myeloproliferative Neoplasm	National Cancer Institute (NCI)	2013-12-16	PHASE1
NCT04562792	Completed	Relapsed Pediatric ALL\|Relapsed Pediatric AML\|Refractory Acute Myeloid Leukemia\|Refractory Acute Lymphoblastic Leukemia	Children''s Mercy Hospital Kansas City	2020-05-08	Phase 2
NCT03298984	COMPLETED	Acute Myeloid Leukemia	Sumitomo Pharma America, Inc.	2017-09-25	PHASE1
NCT02036489	COMPLETED	Acute Lymphobkastic Leukemia	PETHEMA Foundation	2008-01	PHASE4
NCT02283177	COMPLETED	Newly Diagnosed AML With FLT3 Activating Mutations	Arog Pharmaceuticals, Inc.	2015-01	PHASE2
NCT03444649	WITHDRAWN	AML	Insel Gruppe AG, University Hospital Bern	2018-09	PHASE1
NCT03878927	Terminated	Acute Myeloid Leukemia	Weill Medical College of Cornell University\|Jazz Pharmaceuticals\|Pfizer	2019-08-23	Phase 1
NCT02393859	COMPLETED	Leukemia, Acute Lymphoblastic	Amgen	2015-11-10	PHASE3
NCT03896269	Recruiting	Blasts 10-19 Percent of Bone Marrow Nucleated Cells\|Blasts More Than 5 Percent of Bone Marrow Nucleated Cells\|High Risk Chronic Myelomonocytic Leukemia\|Recurrent Chronic Myelomonocytic Leukemia\|Recurrent High Risk Myelodysplastic Syndrome\|Refractory Chronic Myelomonocytic Leukemia\|Refractory High Risk Myelodysplastic Syndrome	M.D. Anderson Cancer Center\|National Cancer Institute (NCI)	2019-05-14	Phase 1
NCT02914977	COMPLETED	Acute Lymphocytic Leukemia; Acute Myeloid Leukemia	Tara Lin	2016-11	PHASE1
NCT03135028	TERMINATED	Hematologic Malignancy; Acute Myeloid Leukemia	Gilead Sciences	2017-05-19	PHASE1
NCT02642965	COMPLETED	Acute Myeloid Leukemia Post Cytotoxic Therapy; Recurrent Childhood Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia	Children's Oncology Group	2016-05-02	PHASE1; PHASE2
NCT02894645	UNKNOWN	Acute Lymphoblastic Leukemia (ALL)	National University Hospital, Singapore	2008-10	PHASE4
NCT02343939	TERMINATED	Acute Myeloid Leukemia	Gilead Sciences	2015-07-01	PHASE1; PHASE2
NCT00866749	COMPLETED	Lymphoblastic Leukemia; Lymphoblastic Lymphoma	M.D. Anderson Cancer Center	2006-09-12	PHASE2
NCT02432872	UNKNOWN	Acute Myeloid Leukemia	Jianxiang Wang	2015-04
NCT01156883	COMPLETED	Leukemia	Gruppo Italiano Malattie EMatologiche dell'Adulto	2010-04
NCT02834390	COMPLETED	Acute Myeloid Leukemia	Daiichi Sankyo Co., Ltd.	2016-08-12	PHASE1
NCT02560025	COMPLETED	Acute Myeloid Leukemia	Massachusetts General Hospital	2015-12	PHASE2
NCT01806571	COMPLETED	Untreated Adult Acute Myeloid Leukemia	Mayo Clinic	2015-03-12	PHASE2
NCT02419469	TERMINATED	Leukemia; Precursor-B Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; Lymphoma	M.D. Anderson Cancer Center	2015-11-13	PHASE2
NCT01804101	COMPLETED	Acute Biphenotypic Leukemia; Acute Myeloid Leukemia; Myelodysplastic Syndrome; Untreated Adult Acute Myeloid Leukemia	Fred Hutchinson Cancer Center	2013-05-07
NCT02198482	TERMINATED	Acute Myeloid Leukemia (AML); High-risk Myelodysplastic Syndrome (MDS)	University of Ulm	2016-02	PHASE2
NCT02472626	WITHDRAWN	Untreated Adult Acute Myeloid Leukemia	Wake Forest University Health Sciences	2015-12	PHASE1; PHASE2
NCT01999413	COMPLETED	Acute Myeloid Leukemia (AML)	French Innovative Leukemia Organisation	2013-11	PHASE2
NCT01463046	COMPLETED	Acute Myeloid Leukemia; Advanced Myelodysplastic Syndrome	University of California, San Francisco	2012-01	PHASE1
NCT00850382	COMPLETED	Acute Myeloid Leukemia (AML)	University of Ulm	2009-06	PHASE1; PHASE2
NCT01890746	COMPLETED	Acute Leukaemia	Novartis Pharmaceuticals	2013-09-05	PHASE2
NCT00526409	COMPLETED	Acute Lymphoblastic Leukemia	PETHEMA Foundation	2005-06	PHASE4
NCT01990807	UNKNOWN	Childhood Acute Lymphoblastic Leukemia; Philadelphia Chromosome, Ph^1^, Absent; B-cell Childhood Acute Lymphoblastic Leukemia	Chinese Academy of Medical Sciences	2012-10	PHASE4
NCT00866307	COMPLETED	Acute Lymphoblastic Leukemia; Adult B Acute Lymphoblastic Leukemia; Childhood B Acute Lymphoblastic Leukemia	Children's Oncology Group	2009-02-23	PHASE1
NCT00458848	COMPLETED	Leukemia	Gruppo Italiano Malattie EMatologiche dell'Adulto	2004-10	PHASE2
NCT00369317	COMPLETED	Childhood Acute Basophilic Leukemia; Childhood Acute Eosinophilic Leukemia; Childhood Acute Erythroleukemia (M6); Childhood Acute Megakaryocytic Leukemia (M7); Childhood Acute Minimally Differentiated Myeloid Leukemia (M0); 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 Myelomonocytic Leukemia (M4); Childhood Myelodysplastic Syndromes; de Novo Myelodysplastic Syndromes; Secondary Acute Myeloid Leukemia; Secondary Myelodysplastic Syndromes; Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies	Children's Oncology Group	2007-03	PHASE3
NCT00372593	COMPLETED	Leukemia	Children's Oncology Group	2006-08	PHASE3
NCT01238211	COMPLETED	Acute Myeloid Leukemia; Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1; Core Binding Factor Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Therapy-Related Acute Myeloid Leukemia	National Cancer Institute (NCI)	2010-12-14	PHASE2
NCT00783653	COMPLETED	Acute Myeloid Leukemia	Universitätsklinikum Hamburg-Eppendorf	2008-08	PHASE1; PHASE2
NCT00814164	TERMINATED	Leukemia	Roswell Park Cancer Institute	2008-12	PHASE2
NCT00915252	COMPLETED	Acute Myeloid Leukemia	University Hospital Muenster	2009-07	PHASE2
NCT01382147	COMPLETED	Acute Myeloid Leukemia	Prof. Dr. Wolfgang Hiddemann	2009-07-01	PHASE3
NCT00454480	COMPLETED	Leukemia; Myelodysplastic Syndromes	The University of New South Wales	2006-08	PHASE2; PHASE3
NCT00990054	COMPLETED	Acute Myeloid Leukemia	Genzyme, a Sanofi Company	2009-12	PHASE1
NCT00430118	COMPLETED	Leukemia	University Hospital Schleswig-Holstein	2000-07	PHASE3
NCT00184041	COMPLETED	Acute Lymphoblastic Leukemia	University of Southern California	2004-07	PHASE2
NCT00002766	COMPLETED	Leukemia; Lymphoma	Memorial Sloan Kettering Cancer Center	1996-03	PHASE3
NCT00268229	COMPLETED	Leukemia	The Cleveland Clinic	2003-07	PHASE1
NCT00927498	COMPLETED	Acute Myeloid Leukemia	Acute Leukemia French Association	2007-12	PHASE3
NCT00093600	COMPLETED	Acute Myeloid Leukemia (AML)	Novartis Pharmaceuticals	2004-02	PHASE1
NCT00428558	COMPLETED	Acute Myeloid Leukemia	Assistance Publique - Hôpitaux de Paris	2007-07	PHASE3
NCT00427414	TERMINATED	Sarcoma	AIDS Malignancy Consortium	2008-09	PHASE1
NCT00180167	COMPLETED	Leukemia, Nonlymphocytic, Acute	Technische Universität Dresden	2005-01	PHASE4
NCT00788892	COMPLETED	Acute Myeloid Leukemia	Jazz Pharmaceuticals	2008-10	PHASE2
NCT00715637	UNKNOWN	Secondary Acute Myeloid Leukemia (Secondary AML, sAML)	Antisoma Research	2007-06	PHASE3
NCT00046930	COMPLETED	Leukemia; Myelodysplastic Syndromes	Eastern Cooperative Oncology Group	2002-09-17	PHASE3
NCT00121303	COMPLETED	Leukemia; Myelodysplastic Syndromes	Stichting Hemato-Oncologie voor Volwassenen Nederland	2005-01	PHASE3
NCT00618501	COMPLETED	Leukemia	Asan Medical Center	2005-10	PHASE2
NCT00474006	COMPLETED	ACUTE MYELOGENOUS LEUKEMIA	Cooperative Study Group A for Hematology	2001-08	PHASE3
NCT00136084	COMPLETED	Leukemia, Myelocytic, Acute	St. Jude Children's Research Hospital	2002-08	PHASE3
NCT00003728	UNKNOWN	Leukemia; Lymphoma	European Organisation for Research and Treatment of Cancer - EORTC	1998-12	PHASE3
NCT00004128	UNKNOWN	Leukemia	European Organisation for Research and Treatment of Cancer - EORTC	1999-09	PHASE3
NCT00061945	COMPLETED	Acute Undifferentiated Leukemia; B-cell Adult Acute Lymphoblastic Leukemia; B-cell Childhood Acute Lymphoblastic Leukemia; L1 Adult Acute Lymphoblastic Leukemia; L1 Childhood Acute Lymphoblastic Leukemia; L2 Adult Acute Lymphoblastic Leukemia; L2 Childhood Acute Lymphoblastic Leukemia; Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia; Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia; Philadelphia Chromosome Positive Childhood Precursor Acute Lymphoblastic Leukemia; T-cell Adult Acute Lymphoblastic Leukemia; T-cell Childhood Acute Lymphoblastic Leukemia; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia	National Cancer Institute (NCI)	2003-06	PHASE1; PHASE2
NCT00005945	COMPLETED	Leukemia	Children's Oncology Group	2000-06	PHASE3
NCT00005585	COMPLETED	Leukemia	Children's Oncology Group	2000-04	PHASE3
NCT00085124	COMPLETED	Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; 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); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia	National Cancer Institute (NCI)	2003-12	PHASE3
NCT00003593	COMPLETED	Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms	Children's Oncology Group	1999-06	PHASE3
NCT00066794	COMPLETED	Leukemia	SWOG Cancer Research Network	2004-07	PHASE2
NCT00002798	COMPLETED	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 Myelomonocytic Leukemia (M4); Childhood Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndromes; Refractory Anemia; Refractory Anemia With Excess Blasts; Refractory Anemia With Excess Blasts in Transformation; Refractory Anemia With Ringed Sideroblasts; Secondary Myelodysplastic Syndromes; Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies	National Cancer Institute (NCI)	1996-08	PHASE3
NCT01225874	COMPLETED	Leukemia	Children's Oncology Group	1999-12
NCT00005596	COMPLETED	Leukemia	Children's Oncology Group	2000-04	PHASE3
NCT00002700	COMPLETED	Leukemia; Lymphoma	European Organisation for Research and Treatment of Cancer - EORTC	1995-08	PHASE3
NCT00199056	COMPLETED	Adult Acute Lymphocytic Leukemia	Goethe University	1999-10	PHASE4
NCT00037583	COMPLETED	Acute Myeloid Leukemia	Wyeth is now a wholly owned subsidiary of Pfizer		PHASE2
NCT00023777	COMPLETED	Leukemia	SWOG Cancer Research Network	2001-08	PHASE2
NCT00002471	COMPLETED	Leukemia; Lymphoma	Memorial Sloan Kettering Cancer Center	1990-02	PHASE2
NCT00004056	COMPLETED	Leukemia	Children's Oncology Group	1999-10	PHASE1
NCT00187005	TERMINATED	Acute Lymphoblastic Leukemia	St. Jude Children's Research Hospital	1998-07	PHASE3
NCT00002665	COMPLETED	Leukemia; Neutropenia; Thrombocytopenia	SWOG Cancer Research Network	1995-07	PHASE2
NCT00004217	COMPLETED	Leukemia	SWOG Cancer Research Network	2000-02	PHASE2
NCT00005942	COMPLETED	Chronic Myelomonocytic Leukemia; Previously Treated Myelodysplastic Syndromes; Recurrent Adult Acute Myeloid Leukemia; Refractory Anemia With Excess Blasts; Refractory Anemia With Excess Blasts in Transformation	National Cancer Institute (NCI)	2000-03	PHASE1; PHASE2
NCT00004215	COMPLETED	Anemia; Leukemia; Neutropenia; Thrombocytopenia	Memorial Sloan Kettering Cancer Center	1999-08	PHASE2
NCT00199069	COMPLETED	Adult Acute Lymphocytic Leukemia	Goethe University	1993-04	PHASE4
NCT00343369	UNKNOWN	Leukemia	Universitätsklinikum Hamburg-Eppendorf	2003-01
NCT00002532	UNKNOWN	Leukemia	Hannover Medical School	1993-01	PHASE2
NCT00005823	COMPLETED	Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms	Leukemia Research Fund	1998-12	PHASE3
NCT00018954	COMPLETED	Leukemia; Lymphoma	National Institutes of Health Clinical Center (CC)	1992-10	PHASE2
NCT00002499	UNKNOWN	Leukemia	Grupo Argentino de Tratamiento de la Leucemia Aguda	1990-01	PHASE2; PHASE3
NCT00002531	UNKNOWN	Leukemia	Johann Wolfgang Goethe University Hospital	1993-01	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-30)

Check the Daunorubicin Hydrochloride (Daunomycin) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Daunorubicin Hydrochloride intercalates into DNA and inhibits topoisomerase II, thereby disrupting both DNA and RNA synthesis and inducing cell-cycle arrest and apoptotic cell death. By suppressing nucleic acid replication and promoting apoptosis in rapidly dividing blast cells, this cytotoxic mechanism underlies its clinical utility in treating hematologic malignancies such as acute myeloid leukemia and acute lymphoblastic leukemia.

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>).