Clinical Trials

Mercaptopurine has been evaluated in numerous clinical trials focusing primarily on hematologic malignancies, including pediatric and adult acute lymphoblastic leukemia and lymphoblastic lymphoma, alongside adverse events such as oral mucositis. Spanning early to late clinical phases, these investigations are led by academic institutions, hospital networks, cooperative groups, and corporate sponsors. Recruitment statuses across these studies range from active and recruiting to completed or withdrawn, underscoring the ongoing characterization of this antileukemic agent.

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
NCT07716735 NOT_YET_RECRUITING
Advanced Kidney Carcinoma; Advanced Renal Cell Carcinoma; Hereditary Leiomyomatosis and Renal Cell Carcinoma; Metastatic Kidney Carcinoma; Metastatic Renal Cell Carcinoma; Skin Leiomyoma; Stage III Renal Cell Cancer AJCC v8; Stage IV Renal Cell Cancer AJCC v8; Uterine Corpus Leiomyoma
Jonsson Comprehensive Cancer Center
2026-12-01 PHASE1
NCT06099366 RECRUITING
Lymphoblastic Leukemia in Children
Hee Young Ju
2024-03-05 PHASE2
NCT03959085 RECRUITING
B Acute Lymphoblastic Leukemia; B Lymphoblastic Lymphoma; Central Nervous System Leukemia; Mixed Phenotype Acute Leukemia; Testicular Leukemia
Children's Oncology Group
2019-10-31 PHASE3
NCT07636564 NOT_YET_RECRUITING
Acute Leukemia of Ambiguous Lineage; B Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative; T Acute Lymphoblastic Leukemia
SWOG Cancer Research Network
2026-10-14 PHASE2
NCT07431060 RECRUITING
Langerhans Cell Histiocytosis (LCH)
West China Second University Hospital
2026-02-13
NCT06124157 RECRUITING
B Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
2025-05-30 PHASE2
NCT07227584 RECRUITING
Acute Lymphoblastic Leukemia; Philadelphia Chromosome-Negative Lymphoblastic Leukemia; Acute Lymphoblastic Leukemia (ALL); Leukemia
Dana-Farber Cancer Institute
2026-04-03 PHASE2
NCT04043494 RECRUITING
Lymphoblastic Lymphoma, Childhood
University Hospital Muenster
2019-08-23 PHASE3
NCT06336395 RECRUITING
B Lymphoblastic Leukemia
National University Hospital, Singapore
2020-03-04 PHASE2
NCT06918431 RECRUITING
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative; Lymphoblastic Lymphoma
City of Hope Medical Center
2025-10-10 PHASE2
NCT06317662 RECRUITING
Acute Leukemia of Ambiguous Lineage; B Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
2025-06-05 PHASE2
NCT05848687 RECRUITING
Lymphoblastic Leukemia
Tanja Andrea Gruber
2023-11-03 PHASE1; PHASE2
NCT03643276 RECRUITING
Acute Lymphoblastic Leukemia, Pediatric
Martin Schrappe
2018-07-15 PHASE3
NCT04546399 RECRUITING
Down Syndrome; Recurrent B Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
2020-12-17 PHASE2
NCT07643103 NOT_YET_RECRUITING
Ph- Acute Lymphoblastic Leukemia (Ph-ALL)
Institute of Hematology & Blood Diseases Hospital, China
2026-06-12 PHASE2
NCT06533748 RECRUITING
Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
St. Jude Children's Research Hospital
2025-01-23 PHASE2
NCT03286634 ACTIVE_NOT_RECRUITING
Down Syndrome; Acute Lymphoblastic Leukemia; Childhood Cancer
National Hospital Organization Nagoya Medical Center
2017-04-18 PHASE2
NCT04747912 RECRUITING
Lymphoblastic Leukemia; Acute Lymphoblastic Leukemia; ph+ Acute Lymphoblastic Leukemia
University of Chicago
2021-03-02 PHASE2
NCT07462299 NOT_YET_RECRUITING
Childhood Acute Lymphoblastic Leukemia
The Children's Hospital of Zhejiang University School of Medicine
2026-02-20
NCT05645718 RECRUITING
Leukemia
M.D. Anderson Cancer Center
2023-07-14 PHASE2
NCT01371630 RECRUITING
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1; B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative; Burkitt-Like Lymphoma With 11q Aberration; High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements; High Grade B-Cell Lymphoma, Not Otherwise Specified; Recurrent B Acute Lymphoblastic Leukemia; Recurrent Burkitt Lymphoma; Refractory B Acute Lymphoblastic Leukemia; Refractory Burkitt Lymphoma
M.D. Anderson Cancer Center
2011-08-26 PHASE1; PHASE2
NCT05660473 RECRUITING
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Institute of Hematology & Blood Diseases Hospital, China
2022-08-01 PHASE2
NCT06390319 RECRUITING
T-cell Acute Lymphoblastic Leukemia; T-cell Lymphoma; Mixed Phenotype Acute Leukemia
St. Jude Children's Research Hospital
2024-12-27 PHASE2
NCT03914625 ACTIVE_NOT_RECRUITING
B Acute Lymphoblastic Leukemia; B Lymphoblastic Lymphoma; Down Syndrome
National Cancer Institute (NCI)
2019-07-03 PHASE3
NCT05157971 ACTIVE_NOT_RECRUITING
B Acute Lymphoblastic Leukemia; Ph-Like Acute Lymphoblastic Leukemia
City of Hope Medical Center
2022-03-17 PHASE1
NCT05303792 ACTIVE_NOT_RECRUITING
B Acute Lymphoblastic Leukemia; B Lymphoblastic Lymphoma
Alliance for Clinical Trials in Oncology
2023-06-09 PHASE2
NCT06639958 SUSPENDED
Acute Lymphoblastic Leukemia; Childhood Acute Lymphoblastic Leukemia
Children's Oncology Group
2024-12-04
NCT03150693 RECRUITING
B Acute Lymphoblastic Leukemia
Alliance for Clinical Trials in Oncology
2017-09-20 PHASE3
NCT05681260 RECRUITING
T-cell Lymphoblastic Lymphoma
Children's Cancer Group, China
2023-02-06 PHASE3
NCT04216524 RECRUITING
Blastic Plasmacytoid Dendritic Cell Neoplasm
M.D. Anderson Cancer Center
2020-05-29 PHASE2
NCT06387121 RECRUITING
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Institute of Hematology & Blood Diseases Hospital, China
2024-04-02 PHASE2
NCT03020030 ACTIVE_NOT_RECRUITING
Acute Lymphoblastic Leukemia, Pediatric
Dana-Farber Cancer Institute
2017-03-03 PHASE3
NCT02877303 RECRUITING
B Acute Lymphoblastic Leukemia; B Lymphoblastic Lymphoma
M.D. Anderson Cancer Center
2016-11-01 PHASE2
NCT00501826 RECRUITING
T Acute Lymphoblastic Leukemia; T Lymphoblastic Lymphoma
M.D. Anderson Cancer Center
2007-07-11 PHASE2
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
NCT03571321 RECRUITING
Acute Lymphoblastic Leukemia; ALL, Childhood; ALL
University of Chicago
2019-05-28 PHASE1
NCT01920737 ACTIVE_NOT_RECRUITING
Leukemia
Memorial Sloan Kettering Cancer Center
2013-08-07 PHASE2
NCT02205762 ACTIVE_NOT_RECRUITING
Langerhans Cell Histiocytosis
North American Consortium for Histiocytosis
2016-11-02 PHASE2; PHASE3
NCT03007147 ACTIVE_NOT_RECRUITING
Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia; Mixed Phenotype Acute Leukemia; T Acute Lymphoblastic Leukemia
Children's Oncology Group
2017-08-08 PHASE3
NCT04440267 RECRUITING
Acute Leukemia of Ambiguous Lineage
Institute of Hematology & Blood Diseases Hospital, China
2020-07-08 PHASE2
NCT02723994 COMPLETED
Leukemia
Incyte Corporation
2016-09-30 PHASE2
NCT06199557 RECRUITING
Acute Myeloid Leukemia, Adult; Myelodysplastic Syndromes, Adult
Haukeland University Hospital
2024-05-23 PHASE1; PHASE2
NCT06279767 UNKNOWN
Glioblastoma; Cancer; Temozolomide
The First Affiliated Hospital with Nanjing Medical University
2022-07-01 PHASE1; PHASE2
NCT02688140 COMPLETED
Acute Promyelocytic Leukemia
Technische Universität Dresden
2016-06 PHASE3
NCT05276284 COMPLETED
Solid Tumor, Adult; Metastatic Cancer
Kristoffer Rohrberg
2022-09-01 PHASE1; PHASE2
NCT02881086 COMPLETED
Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
Goethe University
2016-08 PHASE3
NCT05506332 RECRUITING
Acute Myeloid Leukemia, in Relapse; Acute Myeloid Leukemia Refractory
University Hospital, Antwerp
2022-07-15 PHASE1
NCT05032183 TERMINATED
Recurrent Adult Lymphoblastic Lymphoma; Recurrent B Acute Lymphoblastic Leukemia; Recurrent T Acute Lymphoblastic Leukemia; Refractory B Acute Lymphoblastic Leukemia; Refractory Lymphoblastic Lymphoma; Refractory T Acute Lymphoblastic Leukemia
M.D. Anderson Cancer Center
2022-02-17 PHASE1; PHASE2
NCT02303821 COMPLETED
Acute Lymphoblastic Leukemia (ALL)
Amgen
2015-02-16 PHASE1
NCT05192889 ACTIVE_NOT_RECRUITING
Refractory Acute Lymphoblastic Leukemia; Relapsed Acute Lymphoblastic Leukemia
St. Jude Children's Research Hospital
2022-08-25 PHASE1; PHASE2
NCT02845882 ACTIVE_NOT_RECRUITING
Lymphoblastic Lymphoma
Children's Cancer Group, China
2016-01 PHASE3
NCT04773366 UNKNOWN
Langerhans Cell Histiocytosis
Shanghai Children's Medical Center
2018-07-01 PHASE3
NCT02003222 ACTIVE_NOT_RECRUITING
Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
National Cancer Institute (NCI)
2014-05-19 PHASE3
NCT04228393 UNKNOWN
Acute Lymphoblastic Leukemia, Pediatric
Wei Zhao
2020-02-01 PHASE2; PHASE3
NCT02883049 COMPLETED
B Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia, BCR-ABL1-Like; Central Nervous System Leukemia; Testicular Leukemia
National Cancer Institute (NCI)
2012-02-29 PHASE3
NCT03384654 COMPLETED
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Janssen Research & Development, LLC
2018-05-14 PHASE2
NCT02143414 ACTIVE_NOT_RECRUITING
Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1; Recurrent Acute Lymphoblastic Leukemia; Refractory Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
2015-06-30 PHASE2
NCT02553460 ACTIVE_NOT_RECRUITING
Acute Lymphoblastic Leukemia
St. Jude Children's Research Hospital
2016-01-29 PHASE1; PHASE2
NCT02910245 UNKNOWN
Colitis, Ulcerative
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
2016-11 PHASE3
NCT02523976 COMPLETED
Acute,Leukemia, Lymphoid
Institute of Hematology & Blood Diseases Hospital, China
2015-08-01 PHASE2
NCT01117441 COMPLETED
Leukemia
University Hospital Schleswig-Holstein
2010-06 PHASE3
NCT03920813 UNKNOWN
Acute Lymphoblastic Leukemia
Shandong University
2015-01 PHASE4
NCT02200978 COMPLETED
Childhood Acute Promyelocytic Leukemia
South China Children's Leukemia Group
2011-09 PHASE4
NCT01700946 COMPLETED
Recurrent B-Cell Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood B-Lymphoblastic Lymphoma
St. Jude Children's Research Hospital
2013-04-15 PHASE2
NCT02101853 ACTIVE_NOT_RECRUITING
Recurrent B Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
2014-12-17 PHASE3
NCT02852694 COMPLETED
Crohn's Disease
PIBD-Net
2017-02-28 PHASE4
NCT02177071 COMPLETED
Crohn's Disease
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
2015-10-09 PHASE4
NCT03564704 UNKNOWN
Leukemia; Leukemia, Acute; Adult Lymphoblastic Lymphoma; Leukemia, Lymphoblastic; Leukemia, T Cell; Adult Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; Lymphoblastic Leukemia
Nanfang Hospital, Southern Medical University
2016-02-14 PHASE2; PHASE3
NCT03518112 TERMINATED
Philadelphia Chromosome Negative; Recurrent B Acute Lymphoblastic Leukemia; Refractory B Acute Lymphoblastic Leukemia
M.D. Anderson Cancer Center
2018-04-18 PHASE2
NCT01451515 COMPLETED
Lymphoblastic Lymphoma
St. Jude Children's Research Hospital
2012-05-25 PHASE2
NCT03760003 COMPLETED
Ulcerative Colitis
Abivax S.A.
2019-08-13 PHASE2
NCT04770922 Completed
Acute Lymphoblastic Leukemia Pediatric|Adverse Drug Event
Cipherome Inc.|Stanford University
2021-02-23 --
NCT02420717 TERMINATED
Recurrent B Acute Lymphoblastic Leukemia; Recurrent Ph-Like Acute Lymphoblastic Leukemia; Refractory B Acute Lymphoblastic Leukemia; Refractory Ph-Like Acute Lymphoblastic Leukemia
M.D. Anderson Cancer Center
2015-07-15 PHASE2
NCT00550992 UNKNOWN
Leukemia
Dutch Childhood Oncology Group
2006-01
NCT02611492 UNKNOWN
Philadelphia Chromosome Positive Adult Acute Lymphoblastic Leukemia
Assistance Publique - Hôpitaux de Paris
2016-04 PHASE3
NCT02828358 COMPLETED
Acute Leukemia of Ambiguous Lineage; B Acute Lymphoblastic Leukemia; Mixed Phenotype Acute Leukemia
National Cancer Institute (NCI)
2017-04-01 PHASE2
NCT00549848 COMPLETED
Acute Lymphoblastic Leukemia
St. Jude Children's Research Hospital
2007-10-29 PHASE3
NCT02776605 UNKNOWN
ALL
PETHEMA Foundation
2016-06 PHASE2
NCT03553238 UNKNOWN
Leukemia, Acute; Leukemia, T Cell; Leukemia, Lymphoblastic
Nanfang Hospital, Southern Medical University
2016-02-14 PHASE2; PHASE3
NCT02046694 COMPLETED
Acute Lymphoblastic Leukemia (ALL)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2014-01-06 EARLY_PHASE1
NCT03488225 TERMINATED
Acute Lymphoblastic Leukemia in Remission; B Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
M.D. Anderson Cancer Center
2018-03-28 PHASE2
NCT02112916 ACTIVE_NOT_RECRUITING
Adult T Acute Lymphoblastic Leukemia; Ann Arbor Stage II Adult Lymphoblastic Lymphoma; Ann Arbor Stage II Childhood Lymphoblastic Lymphoma; Ann Arbor Stage III Adult Lymphoblastic Lymphoma; Ann Arbor Stage III Childhood Lymphoblastic Lymphoma; Ann Arbor Stage IV Adult Lymphoblastic Lymphoma; Ann Arbor Stage IV Childhood Lymphoblastic Lymphoma; Childhood T Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
2014-10-04 PHASE3
NCT02912676 COMPLETED
Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
Kjeld Schmiegelow
2016-10 PHASE1; PHASE2
NCT02036489 COMPLETED
Acute Lymphobkastic Leukemia
PETHEMA Foundation
2008-01 PHASE4
NCT01228331 COMPLETED
Leukemia
Universitätsklinikum Hamburg-Eppendorf
2010-10 PHASE2; PHASE3
NCT01503632 COMPLETED
Acute Lymphoblastic Leukemia
Children's Oncology Group
2012-02-21 PHASE3
NCT01190930 COMPLETED
Acute Lymphoblastic Leukemia; Adult B Lymphoblastic Lymphoma; Ann Arbor Stage I B Lymphoblastic Lymphoma; Ann Arbor Stage II B Lymphoblastic Lymphoma; Childhood B Acute Lymphoblastic Leukemia; Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1; Childhood B Lymphoblastic Lymphoma; Down Syndrome; Hypodiploid B Acute Lymphoblastic Leukemia; Philadelphia Chromosome Positive
Children's Oncology Group
2010-08-11 PHASE3
NCT03370601 TERMINATED
Inflammatory Bowel Diseases
University Hospital, Lille
2017-01-03
NCT02660762 UNKNOWN
Leukaemia,Lymphoblastic
Sun Yat-sen University
2016-01 PHASE2
NCT03022747 UNKNOWN
Lymphoblastic Leukemia, Acute, Childhood
Vastra Gotaland Region
2017-01 PHASE2
NCT00707083 COMPLETED
Leukemia
Prince of Wales Hospital, Shatin, Hong Kong
2008-05-01 PHASE3
NCT02894645 UNKNOWN
Acute Lymphoblastic Leukemia (ALL)
National University Hospital, Singapore
2008-10 PHASE4
NCT01906671 UNKNOWN
Acute Lymphoblastic Leukemia; 6-mercaptopurine Therapy
Kjeld Schmiegelow
2013-06 PHASE4
NCT00866749 COMPLETED
Lymphoblastic Leukemia; Lymphoblastic Lymphoma
M.D. Anderson Cancer Center
2006-09-12 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
NCT02578511 WITHDRAWN
Acute Lymphoblastic Leukemia in Complete Remission; Lymphoblastic Lymphoma in Complete Remission; Mixed Phenotype Acute Leukemia in Complete Remission
Ehab L Atallah
2017-06-29 PHASE1
NCT02413047 TERMINATED
Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease
Indiana University
2015-05
NCT01256398 COMPLETED
Acute Lymphoblastic Leukemia; Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
National Cancer Institute (NCI)
2010-12-14 PHASE2
NCT01156883 COMPLETED
Leukemia
Gruppo Italiano Malattie EMatologiche dell'Adulto
2010-04
NCT00408005 COMPLETED
T Acute Lymphoblastic Leukemia; T Lymphoblastic Lymphoma
National Cancer Institute (NCI)
2007-01-30 PHASE3
NCT00557193 COMPLETED
Acute Lymphoblastic Leukemia; Acute Undifferentiated Leukemia; Childhood T Acute Lymphoblastic Leukemia
Children's Oncology Group
2008-01-15 PHASE3
NCT02419469 TERMINATED
Leukemia; Precursor-B Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; Lymphoma
M.D. Anderson Cancer Center
2015-11-13 PHASE2
NCT00551460 COMPLETED
Leukemia
SWOG Cancer Research Network
2007-11-15 PHASE2
NCT03022747 Unknown status
Lymphoblastic Leukemia Acute Childhood
Vastra Gotaland Region
2017-01 Phase 2
NCT02419755 TERMINATED
Mixed Lineage Acute Leukemia; Acute Myeloid Leukemia; Acute Lymphoid Leukemia
St. Jude Children's Research Hospital
2015-04-14 PHASE2
NCT02141100 WITHDRAWN
Non-Hodgkin Lymphoma
Kjeld Schmiegelow
2014-07 PHASE1; PHASE2
NCT02228772 COMPLETED
Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; B-cell Adult Acute Lymphoblastic Leukemia; T-cell Adult Acute Lymphoblastic Leukemia
Massachusetts General Hospital
2014-12 PHASE1
NCT00558519 COMPLETED
Leukemia
Alliance for Clinical Trials in Oncology
2008-03-12 PHASE2
NCT00186875 COMPLETED
Acute Lymphoblastic Leukemia; Lymphoma, Lymphoblastic
St. Jude Children's Research Hospital
2003-11 PHASE2
NCT01629628 UNKNOWN
Crohn Disease
Tel-Aviv Sourasky Medical Center
2012-07 PHASE3
NCT00816049 COMPLETED
Acute Lymphoblastic Leukemia
Rigshospitalet, Denmark
2009-01 PHASE3
NCT00381680 COMPLETED
B-cell Childhood Acute Lymphoblastic Leukemia; L1 Childhood Acute Lymphoblastic Leukemia; L2 Childhood Acute Lymphoblastic Leukemia; Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia
Children's Oncology Group
2007-03 PHASE3
NCT00866918 COMPLETED
Childhood Acute Promyelocytic Leukemia With PML-RARA; Myeloid Neoplasm
Children's Oncology Group
2009-03-09 PHASE3
NCT00526175 COMPLETED
Acute Lymphoblastic Leukemia
PETHEMA Foundation
2001-06 PHASE4
NCT00720109 COMPLETED
Acute Lymphoblastic Leukemia; Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1; Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
National Cancer Institute (NCI)
2008-07-14 PHASE2; PHASE3
NCT01432145 COMPLETED
Breast Cancer; Ovarian Cancer
University of Oxford
2011-05 PHASE2
NCT00973752 COMPLETED
Acute Lymphoblastic Leukemia
Massachusetts General Hospital
2009-08 PHASE2
NCT00400946 COMPLETED
Drug/Agent Toxicity by Tissue/Organ; Leukemia
Dana-Farber Cancer Institute
2005-04 PHASE3
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
NCT00103285 COMPLETED
Acute Lymphoblastic Leukemia; Childhood B Acute Lymphoblastic Leukemia
Children's Oncology Group
2005-04-11 PHASE3
NCT00492856 COMPLETED
Leukemia
SWOG Cancer Research Network
2007-06-01 PHASE3
NCT00846703 UNKNOWN
Acute Lymphoblastic Leukemia
Sun Yat-sen University
2008-07 PHASE4
NCT00096135 COMPLETED
Leukemia
Children's Oncology Group
2004-11
NCT00476190 COMPLETED
Acute Lymphoblastic Leukemia
Dana-Farber Cancer Institute
2007-04 PHASE2
NCT01005758 UNKNOWN
Leukemia
Ohio State University Comprehensive Cancer Center
2009-01 PHASE2
NCT01094613 TERMINATED
Crohn's Disease
Teva GTC
2010-11 PHASE1; PHASE2
NCT01358253 COMPLETED
Acute Lymphoblastic Leukemia
Ruijin Hospital
2010-12 PHASE4
NCT00853008 COMPLETED
Acute Lymphoblastic Leukemia
PETHEMA Foundation
2003-01 PHASE4
NCT01697020 COMPLETED
Acute Lymphoblastic Leukemia
Nova Laboratories Limited
2012-09 PHASE1
NCT00262925 TERMINATED
Recurrent Adult Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
2006-06 PHASE2
NCT00482833 COMPLETED
Leukemia
Gruppo Italiano Malattie EMatologiche dell'Adulto
2007-08 PHASE3
NCT01433432 WITHDRAWN
Crohn's Disease
Teva GTC
2011-10 PHASE2
NCT00408278 COMPLETED
Acute Promyelocytic Leukemia
PETHEMA Foundation
2005-07 PHASE4
NCT00430118 COMPLETED
Leukemia
University Hospital Schleswig-Holstein
2000-07 PHASE3
NCT00521950 COMPLETED
Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
ZonMw: The Netherlands Organisation for Health Research and Development
2007-09
NCT00184041 COMPLETED
Acute Lymphoblastic Leukemia
University of Southern California
2004-07 PHASE2
NCT00002766 COMPLETED
Leukemia; Lymphoma
Memorial Sloan Kettering Cancer Center
1996-03 PHASE3
NCT00198991 COMPLETED
Adult Acute Lymphocytic Leukemia
Goethe University
2003-04 PHASE4
NCT00198978 COMPLETED
Adult Acute Lymphocytic Leukemia
Goethe University
2003-01 PHASE4
NCT00131053 UNKNOWN
Lymphoblastic Leukemia, Acute
Japan Adult Leukemia Study Group
2002-09 PHASE2
NCT00514982 WITHDRAWN
Hermanski-Pudlak Syndrome; Colitis; Cytokines; Lymphocytes; Drug Evaluation
National Institute of Allergy and Infectious Diseases (NIAID)
2007-08-07 PHASE2
NCT00131027 UNKNOWN
Lymphoblastic Leukemia, Acute
Japan Adult Leukemia Study Group
2002-09 PHASE3
NCT00671034 COMPLETED
Acute Lymphoblastic Leukemia; Adult B Acute Lymphoblastic Leukemia; Childhood B Acute Lymphoblastic Leukemia
Children's Oncology Group
2008-07-21 PHASE3
NCT00075725 COMPLETED
Acute Lymphoblastic Leukemia; Adult B Acute Lymphoblastic Leukemia; Childhood B Acute Lymphoblastic Leukemia
Children's Oncology Group
2003-12-29 PHASE3
NCT00109837 COMPLETED
Leukemia
SWOG Cancer Research Network
2005-04 PHASE2
NCT00137111 COMPLETED
Lymphoblastic Leukemia, Acute
St. Jude Children's Research Hospital
2000-07-08 PHASE3
NCT00059839 COMPLETED
Lymphoma
Children's Oncology Group
2003-11 PHASE3
NCT00275106 TERMINATED
Lymphoma
Children's Cancer and Leukaemia Group
2004-09 PHASE3
NCT00199017 COMPLETED
Lymphoma, Lymphoblastic
Johann Wolfgang Goethe University Hospital
2004-04 PHASE4
NCT00199004 COMPLETED
Adult Acute Lymphocytic Leukemia
Johann Wolfgang Goethe University Hospital
2004-04 PHASE4
NCT00774982 COMPLETED
Crohns Disease
Teva GTC
2008-12 PHASE1
NCT00548431 COMPLETED
Leukemia, Lymphocytic, Acute
Rigshospitalet, Denmark
2007-12 PHASE2
NCT00003650 COMPLETED
Lymphoma
UNICANCER
1997-02 PHASE3
NCT00136435 COMPLETED
Acute Lymphoblastic Leukemia
Dana-Farber Cancer Institute
2002-06 PHASE2
NCT00176462 COMPLETED
Acute Lymphocytic Leukemia
Rutgers, The State University of New Jersey
2001-02 PHASE2
NCT00004228 COMPLETED
Lymphoma
Children's Oncology Group
2000-06 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
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
NCT00276601 COMPLETED
Leukemia
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2004-10 PHASE2
NCT00962767 COMPLETED
Leukemia, Myelocytic, Acute
Wyeth is now a wholly owned subsidiary of Pfizer
2002-05 PHASE3
NCT00005945 COMPLETED
Leukemia
Children's Oncology Group
2000-06 PHASE3
NCT00764907 UNKNOWN
Leukemia
University Hospital, Motol
2002-11 PHASE3
NCT00002756 COMPLETED
Leukemia
Children's Oncology Group
1996-06 PHASE2
NCT00465933 COMPLETED
Acute Promyelocytic Leukemia
PETHEMA Foundation
1999-03 PHASE4
NCT00005585 COMPLETED
Leukemia
Children's Oncology Group
2000-04 PHASE3
NCT00016302 COMPLETED
T-cell Childhood Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
2001-04
NCT00494897 COMPLETED
Acute Lymphoblastic Leukemia
PETHEMA Foundation
1996-06 PHASE4
NCT00002744 COMPLETED
Leukemia
Children's Oncology Group
1996-05 PHASE3
NCT00002514 COMPLETED
Leukemia
Eastern Cooperative Oncology Group
1993-05-07 PHASE3
NCT00003934 COMPLETED
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Promyelocytic Leukemia (M3); Childhood Acute Promyelocytic Leukemia (M3); Untreated Adult Acute Myeloid Leukemia; Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
National Cancer Institute (NCI)
1999-06 PHASE3
NCT00022737 COMPLETED
Childhood Acute Lymphoblastic Leukemia in Remission; Recurrent Childhood Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
2002-10 PHASE3
NCT00089349 COMPLETED
Recurrent Childhood Acute Lymphoblastic Leukemia
National Cancer Institute (NCI)
2004-07 PHASE2
NCT00187057 COMPLETED
Ataxia-Telangiectasia
St. Jude Children's Research Hospital
2002-09
NCT00613457 COMPLETED
Leukemia
Associazione Italiana Ematologia Oncologia Pediatrica
2000-09 PHASE3
NCT00002812 COMPLETED
Leukemia
Children's Oncology Group
1996-09 PHASE3
NCT00015873 COMPLETED
Leukemia
Dutch Childhood Oncology Group
1999-05 PHASE3
NCT00005603 COMPLETED
Leukemia
Children's Oncology Group
2000-03 PHASE3
NCT00005596 COMPLETED
Leukemia
Children's Oncology Group
2000-04 PHASE3
NCT00526305 COMPLETED
Acute Lymphoblastic Leukemia
PETHEMA Foundation
2000-01 PHASE4
NCT00022126 COMPLETED
Leukemia
Children's Oncology Group
2002-11 PHASE2
NCT00002704 COMPLETED
Leukemia
National Cancer Institute (NCI)
1996-01 PHASE2
NCT00187122 COMPLETED
Lymphoblastic Lymphoma
St. Jude Children's Research Hospital
1993-03
NCT00002700 COMPLETED
Leukemia; Lymphoma
European Organisation for Research and Treatment of Cancer - EORTC
1995-08 PHASE3
NCT00003700 COMPLETED
Leukemia
Alliance for Clinical Trials in Oncology
1999-01 PHASE2
NCT00648336 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
2003-11 PHASE1
NCT00187083 COMPLETED
Acute Lymphoblastic Leukemia
St. Jude Children's Research Hospital
1997-02 PHASE3
NCT00199056 COMPLETED
Adult Acute Lymphocytic Leukemia
Goethe University
1999-10 PHASE4
NCT00199095 COMPLETED
Adult Acute Lymphocytic Leukemia
Goethe University
1997-02 PHASE4
NCT00003671 COMPLETED
Leukemia
Children's Oncology Group
1998-12 PHASE2
NCT00003783 COMPLETED
Leukemia
Children's Oncology Group
1999-03 PHASE2
NCT00602134 COMPLETED
Acute Lymphoblastic Leukemia
Roxane Laboratories
2002-11
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
NCT01230983 COMPLETED
Cardiac Toxicity; Leukemia; Lymphoma
Children's Oncology Group
1996-06 PHASE3
NCT00002618 COMPLETED
Lymphoma
Children's Oncology Group
1994-12 PHASE3
NCT00002785 COMPLETED
Leukemia
Children's Oncology Group
1996-07 PHASE2
NCT00199069 COMPLETED
Adult Acute Lymphocytic Leukemia
Goethe University
1993-04 PHASE4
NCT00002531 UNKNOWN
Leukemia
Johann Wolfgang Goethe University Hospital
1993-01 PHASE2
NCT00343369 UNKNOWN
Leukemia
Universitätsklinikum Hamburg-Eppendorf
2003-01
NCT00003437 UNKNOWN
Leukemia
Medical Research Council
1997-01 PHASE3
NCT00047268 UNKNOWN
Leukemia; Myelodysplastic/Myeloproliferative Neoplasms
European Working Group of MDS in Childhood
1998-07 PHASE3
NCT00004688 COMPLETED
Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Mixed Gliomas; Glioblastoma Multiforme; Recurrent Brain Tumor
Emory University
1996-08 PHASE2
NCT00003423 UNKNOWN
Lymphoma
United Kingdom Children's Cancer Study Group
1995-05 PHASE3
NCT00019409 WITHDRAWN
Leukemia
National Institutes of Health Clinical Center (CC)
1999-10 PHASE3
NCT00287170 COMPLETED
Crohn's Disease
Teva GTC
2006-07 PHASE1; PHASE2
NCT00002701 UNKNOWN
Leukemia
European Organisation for Research and Treatment of Cancer - EORTC
1995-10 PHASE3
NCT00018954 COMPLETED
Leukemia; Lymphoma
National Institutes of Health Clinical Center (CC)
1992-10 PHASE2

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

Check the Mercaptopurine (6-MP) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mercaptopurine is converted into intracellular thiopurine ribonucleotides that inhibit de novo purine nucleotide synthesis and alter RNA and DNA structure and function through metabolite incorporation into nucleic acids. This disruption halts nucleoside interconversion and impairs cellular proliferation, ultimately driving antineoplastic activity against malignant hematopoietic cells in acute lymphoblastic leukemia and pediatric lymphomas.

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.