Numerous clinical trials evaluate Thioguanine across various therapeutic domains, primarily focusing on hematologic malignancies—including acute lymphoblastic leukemia, acute myeloid leukemia, and myelodysplastic syndromes—and inflammatory bowel conditions such as Crohn's disease. Spanning Phase 1 through Phase 4, these investigations exhibit recruitment statuses ranging from active and completed to terminated or withdrawn. They are sponsored by academic medical centers, cooperative research organizations, and regional healthcare institutions, including the Children's Oncology Group, Rigshospitalet Denmark, and the European Organisation for Research and Treatment of Cancer.
| 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 |
| 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 |
| NCT06124157 | RECRUITING | B Acute Lymphoblastic Leukemia |
National Cancer Institute (NCI) |
2025-05-30 | 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 |
| NCT06317662 | RECRUITING | Acute Leukemia of Ambiguous Lineage; B Acute Lymphoblastic Leukemia |
National Cancer Institute (NCI) |
2025-06-05 | PHASE2 |
| NCT06533748 | RECRUITING | Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma |
St. Jude Children's Research Hospital |
2025-01-23 | 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 |
| NCT03150693 | RECRUITING | B Acute Lymphoblastic Leukemia |
Alliance for Clinical Trials in Oncology |
2017-09-20 | PHASE3 |
| 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 |
| 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 |
| NCT02723994 | COMPLETED | Leukemia |
Incyte Corporation |
2016-09-30 | PHASE2 |
| NCT05276284 | COMPLETED | Solid Tumor, Adult; Metastatic Cancer |
Kristoffer Rohrberg |
2022-09-01 | PHASE1; 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 |
| NCT06351306 | WITHDRAWN | Acute Myeloid Leukemia |
Columbia University |
2024-04-01 | PHASE2 |
| 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 |
| NCT01117441 | COMPLETED | Leukemia |
University Hospital Schleswig-Holstein |
2010-06 | PHASE3 |
| NCT02101853 | ACTIVE_NOT_RECRUITING | Recurrent B Acute Lymphoblastic Leukemia |
National Cancer Institute (NCI) |
2014-12-17 | PHASE3 |
| NCT01451515 | COMPLETED | Lymphoblastic Lymphoma |
St. Jude Children's Research Hospital |
2012-05-25 | PHASE2 |
| NCT00550992 | UNKNOWN | Leukemia |
Dutch Childhood Oncology Group |
2006-01 | |
| 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 |
| 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 |
| NCT01228331 | COMPLETED | Leukemia |
Universitätsklinikum Hamburg-Eppendorf |
2010-10 | PHASE2; 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 |
| NCT02660762 | UNKNOWN | Leukaemia,Lymphoblastic |
Sun Yat-sen University |
2016-01 | PHASE2 |
| NCT02894645 | UNKNOWN | Acute Lymphoblastic Leukemia (ALL) |
National University Hospital, Singapore |
2008-10 | PHASE4 |
| NCT00866749 | COMPLETED | Lymphoblastic Leukemia; Lymphoblastic Lymphoma |
M.D. Anderson Cancer Center |
2006-09-12 | 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 |
| NCT02419469 | TERMINATED | Leukemia; Precursor-B Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; Lymphoma |
M.D. Anderson Cancer Center |
2015-11-13 | PHASE2 |
| NCT03022747 | Unknown status | Lymphoblastic Leukemia Acute Childhood |
Vastra Gotaland Region |
2017-01 | Phase 2 |
| NCT02141100 | WITHDRAWN | Non-Hodgkin Lymphoma |
Kjeld Schmiegelow |
2014-07 | PHASE1; PHASE2 |
| NCT00558519 | COMPLETED | Leukemia |
Alliance for Clinical Trials in Oncology |
2008-03-12 | PHASE2 |
| NCT04304950 | Completed | Inflammatory Bowel Diseases |
Rush University Medical Center |
2016-04-25 | Phase 4 |
| NCT00866307 | COMPLETED | Acute Lymphoblastic Leukemia; Adult B Acute Lymphoblastic Leukemia; Childhood B Acute Lymphoblastic Leukemia |
Children's Oncology Group |
2009-02-23 | PHASE1 |
| NCT00103285 | COMPLETED | Acute Lymphoblastic Leukemia; Childhood B Acute Lymphoblastic Leukemia |
Children's Oncology Group |
2005-04-11 | PHASE3 |
| 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 |
| NCT00430118 | COMPLETED | Leukemia |
University Hospital Schleswig-Holstein |
2000-07 | PHASE3 |
| NCT00184041 | COMPLETED | Acute Lymphoblastic Leukemia |
University of Southern California |
2004-07 | PHASE2 |
| NCT00849368 | COMPLETED | Inflammatory Bowel Disease |
University of Zurich |
2009-01 | PHASE1 |
| NCT00198991 | COMPLETED | Adult Acute Lymphocytic Leukemia |
Goethe University |
2003-04 | PHASE4 |
| 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 |
| NCT00504660 | COMPLETED | Anaplastic Glioma of Brain; Glioblastoma Multiforme; Brain Cancer |
M.D. Anderson Cancer Center |
2003-09 | PHASE2 |
| NCT00002517 | COMPLETED | Leukemia; Myelodysplastic Syndromes |
European Organisation for Research and Treatment of Cancer - EORTC |
1993-03 | PHASE3 |
| NCT00275106 | TERMINATED | Lymphoma |
Children's Cancer and Leukaemia Group |
2004-09 | PHASE3 |
| NCT00439296 | TERMINATED | Recurrent Pediatric ALL; Relapsed Pediatric ALL; Acute Lymphoblastic Leukemia; Refractory Pediatric ALL |
Therapeutic Advances in Childhood Leukemia Consortium |
2006-05-22 | PHASE1; PHASE2 |
| NCT00186966 | COMPLETED | Acute Myeloid Leukemia |
Dutch Childhood Oncology Group |
2002-03 | 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 |
| 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 |
| NCT00588536 | COMPLETED | Langerhans Cell Histiocytosis |
Memorial Sloan Kettering Cancer Center |
1995-01 | PHASE2 |
| NCT00003728 | UNKNOWN | Leukemia; Lymphoma |
European Organisation for Research and Treatment of Cancer - EORTC |
1998-12 | PHASE3 |
| NCT00548431 | Completed | Leukemia Lymphocytic Acute |
Rigshospitalet Denmark |
2007-12 | Phase 2 |
| NCT00005945 | COMPLETED | Leukemia |
Children's Oncology Group |
2000-06 | PHASE3 |
| NCT00764907 | UNKNOWN | Leukemia |
University Hospital, Motol |
2002-11 | PHASE3 |
| 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 | |
| NCT00003593 | COMPLETED | Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms |
Children's Oncology Group |
1999-06 | PHASE3 |
| NCT00002744 | COMPLETED | Leukemia |
Children's Oncology Group |
1996-05 | PHASE3 |
| NCT00266136 | COMPLETED | Acute Myeloid Leukemia |
University Hospital Muenster |
1999-06 | PHASE3 |
| NCT00002514 | COMPLETED | Leukemia |
Eastern Cooperative Oncology Group |
1993-05-07 | PHASE3 |
| 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 |
| NCT00613457 | COMPLETED | Leukemia |
Associazione Italiana Ematologia Oncologia Pediatrica |
2000-09 | PHASE3 |
| NCT00002812 | COMPLETED | Leukemia |
Children's Oncology Group |
1996-09 | PHASE3 |
| NCT00002944 | COMPLETED | Brain Tumors; Central Nervous System Tumors |
Children's Oncology Group |
1997-04 | PHASE3 |
| NCT00005603 | COMPLETED | Leukemia |
Children's Oncology Group |
2000-03 | PHASE3 |
| NCT00005596 | COMPLETED | Leukemia |
Children's Oncology Group |
2000-04 | PHASE3 |
| NCT00098111 | Terminated | Crohn''s Disease |
Massachusetts General Hospital |
2005-04 | Phase 3 |
| NCT00022126 | COMPLETED | Leukemia |
Children's Oncology Group |
2002-11 | PHASE2 |
| NCT00587873 | COMPLETED | Hodgkin's Disease |
Memorial Sloan Kettering Cancer Center |
1994-03 | PHASE2 |
| NCT00199056 | COMPLETED | Adult Acute Lymphocytic Leukemia |
Goethe University |
1999-10 | PHASE4 |
| NCT00002816 | COMPLETED | Leukemia |
Children's Oncology Group |
1996-12 | PHASE3 |
| NCT00003671 | COMPLETED | Leukemia |
Children's Oncology Group |
1998-12 | PHASE2 |
| NCT00004056 | COMPLETED | Leukemia |
Children's Oncology Group |
1999-10 | PHASE1 |
| NCT00002665 | COMPLETED | Leukemia; Neutropenia; Thrombocytopenia |
SWOG Cancer Research Network |
1995-07 | PHASE2 |
| NCT00002590 | COMPLETED | Lymphoma |
Children's Oncology Group |
1994-07 | PHASE2 |
| NCT00199069 | COMPLETED | Adult Acute Lymphocytic Leukemia |
Goethe University |
1993-04 | PHASE4 |
| NCT00005823 | COMPLETED | Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms |
Leukemia Research Fund |
1998-12 | PHASE3 |
| NCT00002701 | UNKNOWN | Leukemia |
European Organisation for Research and Treatment of Cancer - EORTC |
1995-10 | PHASE3 |
| 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 |
| NCT00003423 | UNKNOWN | Lymphoma |
United Kingdom Children's Cancer Study Group |
1995-05 | PHASE3 |
| NCT00002658 | UNKNOWN | Leukemia; Neutropenia |
Medical Research Council |
1994-01 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-07-30)
Check the
Thioguanine
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.