Numerous clinical trials evaluate cladribine across autoimmune and hematologic conditions, predominantly multiple sclerosis, acute myeloid leukemia, hairy cell leukemia, and myelodysplastic syndromes. Spanning Phase 1 through Phase 4 studies alongside observational evaluations, these trials encompass active, recruiting, completed, terminated, and withdrawn protocols. Supported by pharmaceutical sponsors like Merck KGaA and academic institutes such as M.D. Anderson Cancer Center and the National Cancer Institute, these initiatives reflect comprehensive clinical research in neuroimmunology and oncology.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07517185 | RECRUITING | Relapsing-remitting Multiple Sclerosis |
Uppsala University |
2026-09-01 | PHASE2 |
| NCT02115295 | RECRUITING | Acute Biphenotypic Leukemia; Acute Myeloid Leukemia; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Blasts 10 Percent or More of Bone Marrow Nucleated Cells; Blasts 10 Percent or More of Peripheral Blood White Cells; de Novo Myelodysplastic Syndrome; Myelodysplastic Syndrome; Previously Treated Myelodysplastic Syndrome; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Acute Myeloid Leukemia; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia |
M.D. Anderson Cancer Center |
2014-05-19 | PHASE2 |
| NCT06965114 | RECRUITING | Hairy Cell Leukemia; Recurrent Hairy Cell Leukemia; Refractory Hairy Cell Leukemia |
National Cancer Institute (NCI) |
2026-05-29 | PHASE1; PHASE2 |
| NCT05766514 | WITHDRAWN | Acute Myeloid Leukemia; Myelodysplastic Syndromes |
University of Florida |
2025-04 | PHASE2 |
| NCT07757672 | NOT_YET_RECRUITING | AML (Acute Myelogenous Leukemia; HSCT |
Institute of Hematology & Blood Diseases Hospital, China |
2026-09-01 | PHASE1; PHASE2 |
| NCT07500753 | RECRUITING | Relapsed or Refractory Acute Myeloid Leukemia (AML); MDS (Myelodysplastic Syndrome) |
The First Affiliated Hospital of Soochow University |
2026-04-01 | |
| NCT07423104 | NOT_YET_RECRUITING | Acute Myeloid Leukemia (AML) |
University of Rochester |
2026-08-15 | PHASE2 |
| NCT07311746 | RECRUITING | T-cell Prolymphocytic Leukemia; Refractory T-Cell Prolymphocytic Leukemia |
M.D. Anderson Cancer Center |
2026-04-28 | PHASE1; PHASE2 |
| NCT06133556 | NOT_YET_RECRUITING | Acute Myeloid Leukemia |
Institute of Hematology & Blood Diseases Hospital, China |
2023-11-24 | PHASE2 |
| NCT06463587 | RECRUITING | Generalized Myasthenia Gravis |
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany |
2024-06-25 | PHASE3 |
| NCT07053020 | NOT_YET_RECRUITING | Acute Myeloid Leukemia (AML) |
M.D. Anderson Cancer Center |
2027-12-01 | PHASE1; PHASE2 |
| NCT01515527 | RECRUITING | Leukemia |
M.D. Anderson Cancer Center |
2012-02-07 | PHASE2 |
| NCT05365035 | RECRUITING | Myelodysplastic Syndromes; Myeloproliferative Chronic Myelomonocytic Leukemia |
M.D. Anderson Cancer Center |
2022-09-23 | PHASE2 |
| NCT03589729 | RECRUITING | Acute Myeloid Leukemia; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Blasts 10 Percent or More of Bone Marrow Nucleated Cells; High Risk Myelodysplastic Syndrome; Myeloid Sarcoma; Myeloproliferative Neoplasm; Philadelphia Chromosome Positive |
M.D. Anderson Cancer Center |
2018-09-19 | 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 |
| NCT04047641 | RECRUITING | Acute Myeloid Leukemia; Blasts 20 Percent or More of Bone Marrow Nucleated Cells; High Risk Myelodysplastic Syndrome; Recurrent Acute Biphenotypic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent High Risk Myelodysplastic Syndrome; Refractory Acute Myeloid Leukemia; Refractory High Risk Myelodysplastic Syndrome |
M.D. Anderson Cancer Center |
2019-10-22 | PHASE1; PHASE2 |
| NCT04708054 | RECRUITING | Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia; Myelodysplastic Syndrome |
M.D. Anderson Cancer Center |
2021-10-21 | PHASE2; PHASE3 |
| NCT04695080 | ACTIVE_NOT_RECRUITING | Advanced Multiple Sclerosis; Progressive Multiple Sclerosis |
Queen Mary University of London |
2021-06-25 | PHASE2; PHASE3 |
| NCT04861207 | ACTIVE_NOT_RECRUITING | Acute Myeloid Leukemia Myelodysplastic Syndromes |
Maria Sklodowska-Curie National Research Institute of Oncology |
2021-10-07 | PHASE2 |
| NCT06660368 | RECRUITING | Relapsed or Refractory Acute Myeloid Leukemia (AML) |
H. Lee Moffitt Cancer Center and Research Institute |
2024-11-26 | PHASE2 |
| NCT02250937 | ACTIVE_NOT_RECRUITING | Acute Myeloid Leukemia; Myelodysplastic Syndrome |
M.D. Anderson Cancer Center |
2014-10-27 | PHASE2 |
| NCT06504459 | RECRUITING | Acute Monocytic Leukemia; Acute Myeloid Leukemia |
OHSU Knight Cancer Institute |
2025-01-03 | PHASE2 |
| NCT06561152 | RECRUITING | Refractory Acute Myeloid Leukemia; Relapsed Acute Myeloid Leukemia |
Stanford University |
2025-02-10 | PHASE1; PHASE2 |
| NCT06561360 | RECRUITING | Hairy Cell Leukemia |
Memorial Sloan Kettering Cancer Center |
2024-09-09 | PHASE2 |
| NCT06532552 | RECRUITING | Acute Myeloid Leukemia, Adult; Newly Diagnosed |
The First Affiliated Hospital of Soochow University |
2024-07-29 | PHASE2 |
| NCT04050280 | RECRUITING | Acute Myeloid Leukemia, Adult; Acute Myeloid Leukemia Recurrent; Acute Myeloid Leukemia, Relapsed, Adult |
University of Maryland, Baltimore |
2019-11-01 | PHASE2 |
| NCT00412594 | RECRUITING | Hairy Cell Leukemia; Recurrent Hairy Cell Leukemia |
M.D. Anderson Cancer Center |
2004-06-10 | PHASE2 |
| NCT05961644 | RECRUITING | Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis |
Institute of Psychiatry and Neurology, Warsaw |
2022-10-03 | PHASE2; PHASE3 |
| NCT07032727 | RECRUITING | Targeted Therapy; IDH1-Mutated Malignancies; Mutations |
M.D. Anderson Cancer Center |
2025-09-12 | PHASE2 |
| NCT05330377 | WITHDRAWN | Acute Myeloid Leukemia |
Ayman H Qasrawi |
2023-03 | PHASE1 |
| NCT03586609 | RECRUITING | Acute Myeloid Leukemia |
M.D. Anderson Cancer Center |
2018-10-25 | 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 |
| NCT03477500 | ACTIVE_NOT_RECRUITING | Multiple Sclerosis |
Haukeland University Hospital |
2018-03-21 | PHASE3 |
| NCT05657639 | RECRUITING | Acute Myeloid Leukemia |
The First Affiliated Hospital of Soochow University |
2022-10-01 | PHASE2 |
| NCT05657652 | RECRUITING | Acute Lymphoblastic Leukemia |
The First Affiliated Hospital of Soochow University |
2022-10-01 | |
| NCT06060782 | RECRUITING | Burkitt Lymphoma; Lymphoblastic Lymphoma, Adult; Acute Lymphoblastic Leukemia, Adult |
Fifth Affiliated Hospital, Sun Yat-Sen University |
2024-03-06 | PHASE1 |
| NCT04178005 | ACTIVE_NOT_RECRUITING | Multiple Sclerosis |
University of Texas Southwestern Medical Center |
2020-02-19 | PHASE4 |
| NCT03500328 | ACTIVE_NOT_RECRUITING | Multiple Sclerosis, Relapsing-Remitting |
Johns Hopkins University |
2018-05-02 | |
| NCT06232655 | ACTIVE_NOT_RECRUITING | Acute Myeloid Leukemia |
University of Colorado, Denver |
2024-02-08 | PHASE2 |
| NCT05313958 | UNKNOWN | Leukemia, Monocytic, Acute; Pediatric AML |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
2021-12-01 | PHASE2; PHASE3 |
| NCT06021600 | TERMINATED | Leukemia; Myelodysplastic Syndromes; Acute Myeloid Leukemia |
M.D. Anderson Cancer Center |
2023-10-09 | PHASE1 |
| NCT05870995 | RECRUITING | Refractory Leukemia |
Shanghai Jiao Tong University School of Medicine |
2023-02-01 | PHASE2 |
| NCT03926624 | TERMINATED | Leukemia, Myeloid, Acute |
Delta-Fly Pharma, Inc. |
2019-11-22 | PHASE3 |
| NCT05466318 | UNKNOWN | Lymphoma, Large B-Cell, Diffuse; Lymphoma, T-Cell |
Sichuan University |
2022-07-01 | PHASE3 |
| NCT06007911 | WITHDRAWN | Relapsed Adult AML; Refractory AML |
Medical College of Wisconsin |
2024-08-31 | PHASE1 |
| NCT02131753 | RECRUITING | Hairy Cell Leukemia |
University of Giessen |
2004-05 | PHASE2; PHASE3 |
| NCT06474663 | WITHDRAWN | Refractory Acute Leukemia; Relapsed Acute Leukemia |
M.D. Anderson Cancer Center |
2025-07-31 | PHASE1 |
| NCT04195945 | COMPLETED | Acute Myeloid Leukemia; Myeloid Neoplasm |
Fred Hutchinson Cancer Center |
2020-05-27 | PHASE2 |
| NCT06763666 | NOT_YET_RECRUITING | Relapsed/Refractory AML |
Nanfang Hospital, Southern Medical University |
2025-02 | PHASE4 |
| NCT03963375 | COMPLETED | Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting |
Gregory Wu |
2019-10-28 | PHASE4 |
| NCT05906914 | COMPLETED | Acute Myeloid Leukemia, Adult |
First Affiliated Hospital of Zhejiang University |
2022-10-26 | PHASE2 |
| NCT03150004 | TERMINATED | Acute Myeloid Leukemia; Myelodysplastic Syndrome |
Medical College of Wisconsin |
2017-06-14 | PHASE2 |
| NCT04550455 | UNKNOWN | Multiple Sclerosis |
Keith Edwards, M.D. |
2020-09-16 | PHASE4 |
| NCT05190549 | COMPLETED | Acute Leukemia, Relapsed; Acute Leukemia Refractory |
The First Affiliated Hospital of Soochow University |
2021-10-01 | PHASE2 |
| NCT04848974 | COMPLETED | Secondary Acute Myeloid Leukemia |
M.D. Anderson Cancer Center |
2021-06-11 | PHASE1; PHASE2 |
| NCT04880746 | UNKNOWN | Peripheral T-cell Lymphoma |
Ruijin Hospital |
2020-10-17 | PHASE3 |
| NCT04121403 | COMPLETED | Relapsing Multiple Sclerosis; Multiple Sclerosis |
Oslo University Hospital |
2019-10-16 | PHASE3 |
| NCT05902429 | UNKNOWN | Multiple Sclerosis, Relapsing-Remitting |
Pontificia Universidade Católica do Rio Grande do Sul |
2021-04-28 | PHASE4 |
| NCT00923013 | ACTIVE_NOT_RECRUITING | Hairy Cell Leukemia |
National Cancer Institute (NCI) |
2008-10-20 | PHASE2 |
| NCT03441048 | COMPLETED | Acute Myeloid Leukemia |
Medical College of Wisconsin |
2018-05-22 | PHASE1 |
| NCT05578378 | UNKNOWN | Acute Lymphoblastic Leukemia |
The First Affiliated Hospital of Soochow University |
2022-01-01 | PHASE2; PHASE3 |
| NCT02910752 | SUSPENDED | Leukemia |
Shanghai Jiao Tong University School of Medicine |
2016-09 | PHASE1; PHASE2 |
| NCT05797740 | Recruiting | Multiple Sclerosis |
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany |
2023-08-03 | -- |
| NCT04254640 | UNKNOWN | Acute Myeloid Leukemia; Elderly Patients; Newly Diagnosed |
Sun Yat-sen University |
2021-03-01 | PHASE2 |
| NCT05330364 | UNKNOWN | Acute Myeloid Leukemia |
Ge Zheng |
2021-06-01 | PHASE2 |
| NCT05053425 | UNKNOWN | Acute Myeloid Leukemia |
LanZhou University |
2021-10-20 | |
| NCT03745144 | COMPLETED | Relapsing Multiple Sclerosis (RMS) |
Merck KGaA, Darmstadt, Germany |
2019-01-17 | PHASE1 |
| NCT03384225 | UNKNOWN | High Risk Acute Myeloid Leukemia; Allogeneic Hematopoeitic Stem Cell Transplantation |
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
2016-08-01 | PHASE3 |
| NCT03384212 | UNKNOWN | High Risk Acute Myeloid Leukemia; Allogeneic Hematopoeitic Stem Cell Transplantation |
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
2016-08-01 | 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 |
| NCT04821596 | COMPLETED | Multiple Sclerosis |
University Hospital, Rouen |
2020-07-13 | |
| NCT04196010 | TERMINATED | Myeloid Neoplasm; Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia |
University of Washington |
2020-05-08 | PHASE1 |
| NCT03882203 | COMPLETED | Refractory Hematologic Cancer; Allogeneic Stem Cell Transplantation |
Shanghai Jiao Tong University School of Medicine |
2018-08-01 | PHASE2 |
| NCT04997148 | Completed | Relapsing-Remitting Multiple Sclerosis |
Merck Healthcare KGaA Darmstadt Germany an affiliate of Merck KGaA Darmstadt Germany|Merck Serono Limited an affiliate of Merck KGaA Darmstadt Germany |
2021-08-11 | -- |
| NCT03531918 | COMPLETED | Acute Myeloid Leukemia |
Fred Hutchinson Cancer Center |
2018-09-14 | PHASE1; PHASE2 |
| NCT03961204 | COMPLETED | Multiple Sclerosis (MS) |
EMD Serono Research & Development Institute, Inc. |
2019-08-15 | PHASE4 |
| NCT03602131 | UNKNOWN | Hodgkin Lymphoma; Non-hodgkin Lymphoma |
Sichuan University |
2019-01-01 | PHASE2 |
| NCT03012672 | COMPLETED | Acute Leukemia of Ambiguous Lineage; Acute Myeloid Leukemia; Myeloid Neoplasm |
University of Washington |
2016-12-30 | PHASE2 |
| NCT03151876 | UNKNOWN | Lymphoma |
Sichuan University |
2017-06-12 | PHASE2 |
| NCT02096055 | COMPLETED | Untreated Adult Acute Myeloid Leukemia |
M.D. Anderson Cancer Center |
2014-04-04 | PHASE2 |
| NCT03235973 | UNKNOWN | Leukemia, Myeloid, Acute; Leukemia, Lymphoblastic, Acute |
Institut Paoli-Calmettes |
2018-04-28 | PHASE1 |
| 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 |
| NCT03318419 | UNKNOWN | Acute Lymphoblastic Leukemia |
Sun Yat-sen University |
2016-01-01 | PHASE2 |
| NCT03181815 | UNKNOWN | Acute Myeloid Leukemia; Relapse Leukemia |
Sun Yat-sen University |
2016-01-01 | PHASE2 |
| NCT03491579 | WITHDRAWN | AML; Relapse |
Insel Gruppe AG, University Hospital Bern |
2018-12 | PHASE1 |
| NCT02416908 | COMPLETED | Acute Myeloid Leukemia |
Washington University School of Medicine |
2015-06-16 | PHASE1; PHASE2 |
| 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 |
| NCT01439750 | UNKNOWN | Mantle Cell Lymphoma |
Milton S. Hershey Medical Center |
2012-05 | PHASE1 |
| NCT01473797 | UNKNOWN | Langerhans Cell Histiocytosis of Lung |
Assistance Publique - Hôpitaux de Paris |
2011-11 | 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 |
| NCT01446900 | TERMINATED | Chronic Lymphocytic Leukaemia; Small Lymphocytic Lymphoma |
European Institute of Oncology |
2011-01 | PHASE2 |
| NCT01602939 | UNKNOWN | Systemic Mastocytosis |
Hospital Virgen de la Salud |
2012-05 | PHASE2; PHASE3 |
| NCT01272817 | COMPLETED | Aplastic Anemia; Paroxysmal Nocturnal Hemoglobinuria; Acute Myelogenous Leukemia; Acute Lymphocytic Leukemia; Myelodysplastic Syndrome; Chronic Myelogenous Leukemia; Chronic Lymphocytic Leukemia; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma; Multiple Myeloma; Waldenstrom Macroglobulinemia; Breast Cancer; Renal Cell Carcinoma; Melanoma; Sarcoma; Ovarian Cancer; Thymoma |
Scripps Health |
2001-10 | |
| NCT00718549 | COMPLETED | Lymphocytic Leukemia, Chronic |
Hoffmann-La Roche |
2009-07-21 | PHASE3 |
| NCT00764517 | COMPLETED | Recurrent B-Cell Non-Hodgkin Lymphoma; Recurrent Chronic Lymphocytic Leukemia; Recurrent Indolent Adult Non-Hodgkin Lymphoma; Refractory B-Cell Non-Hodgkin Lymphoma |
OHSU Knight Cancer Institute |
2008-08 | PHASE2 |
| NCT00980395 | COMPLETED | Lymphoma; Mantle Cell Lymphoma; Indolent Lymphoma; SLL |
University of Arizona |
2009-07-07 | PHASE2 |
| NCT00787969 | COMPLETED | Lymphoma |
Alliance for Clinical Trials in Oncology |
2009-04 | PHASE1 |
| NCT00641537 | COMPLETED | Relapsing-Remitting Multiple Sclerosis |
EMD Serono Research & Development Institute, Inc. |
2008-02-29 | PHASE3 |
| NCT00436826 | COMPLETED | Multiple Sclerosis |
EMD Serono Research & Development Institute, Inc. |
2006-11-30 | PHASE2 |
| NCT01161550 | COMPLETED | Leukemia, Myeloid, Acute |
Washington University School of Medicine |
2010-11 | PHASE1 |
| NCT00725985 | COMPLETED | Multiple Sclerosis |
EMD Serono Research & Development Institute, Inc. |
2008-12-31 | PHASE3 |
| NCT00198991 | COMPLETED | Adult Acute Lymphocytic Leukemia |
Goethe University |
2003-04 | PHASE4 |
| NCT00126321 | UNKNOWN | Leukemia, Myelocytic, Acute |
University Hospital, Bonn |
2004-11 | PHASE2 |
| NCT00199017 | COMPLETED | Lymphoma, Lymphoblastic |
Johann Wolfgang Goethe University Hospital |
2004-04 | PHASE4 |
| NCT00938366 | COMPLETED | Multiple Sclerosis |
Merck KGaA, Darmstadt, Germany |
2008-01 | PHASE1 |
| NCT00213135 | COMPLETED | Multiple Sclerosis, Relapsing-Remitting |
EMD Serono |
2005-04 | PHASE3 |
| NCT00136084 | COMPLETED | Leukemia, Myelocytic, Acute |
St. Jude Children's Research Hospital |
2002-08 | PHASE3 |
| NCT00199030 | COMPLETED | Adult Acute Lymphocytic Leukemia T-cell; Lymphoma, Lymphoblastic |
Goethe University |
2004-02 | PHASE2 |
| NCT00258271 | COMPLETED | Leukemia |
University of Rochester |
2005-03 | PHASE1 |
| NCT00053027 | COMPLETED | Lymphoma |
Alliance for Clinical Trials in Oncology |
2003-02 | PHASE2 |
| NCT00003174 | COMPLETED | Leukemia |
Barbara Ann Karmanos Cancer Institute |
1998-05 | PHASE1 |
| NCT00002879 | COMPLETED | Lymphoma |
Alliance for Clinical Trials in Oncology |
1996-11 | PHASE2 |
| NCT00003178 | COMPLETED | Leukemia |
Children's Oncology Group |
1998-03 | PHASE2 |
| NCT00072007 | COMPLETED | Leukemia |
Swiss Cancer Institute |
2002-06 | PHASE2 |
| NCT00002833 | COMPLETED | Graft Versus Host Disease; Leukemia; Myelodysplastic Syndromes |
M.D. Anderson Cancer Center |
1994-10 | PHASE2 |
| NCT00002805 | COMPLETED | Leukemia |
Children's Oncology Group |
1997-08 | PHASE2 |
| NCT00004904 | COMPLETED | Chronic Myeloproliferative Disorders; Graft Versus Host Disease; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Precancerous/Nonmalignant Condition; Small Intestine Cancer |
Northwestern University |
1999-10 | PHASE1 |
| NCT00004762 | COMPLETED | Cholangitis, Sclerosing |
National Center for Research Resources (NCRR) |
1994-12 | PHASE2 |
| NCT00019071 | COMPLETED | Brain and Central Nervous System Tumors |
National Cancer Institute (NCI) |
1995-03 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-09-03)
Check the
Cladribine
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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.