12 recruiting, 11 completed, 4 active not recruiting, 3 terminated. 34 Phase 2, 9 Phase 1, 1 Phase 3.
Follow 5-Azacitidine: new trials by email Literature Review of 5-Azacitidine trials Research Report on 5-Azacitidine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Testing the Investigational Medication Combination of Azacitidine, Venetoclax, and Quizartinib Compared to the Usual Treatment of Cytarabine, Daunorubicin, and Quizartinib for Patients With FLT3-ITD Mutant Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) Azacitidine, Biospecimen Collection, Bone Marrow Aspiration - Acute Myeloid Leukemia | Phase 2 | Not yet recruiting | National Cancer Institute (NCI) | 122 | 2027-01-15 | 2026-10-07 |
| Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia Following Initial Treatment, The ERASE Study (A MyeloMATCH Treatment Trial) Azacitidine, Bone Marrow Aspiration and Biopsy, Cytarabine - Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome | Phase 2 | Not yet recruiting | National Cancer Institute (NCI) | 184 | 2027-01-04 | 2026-10-01 |
| Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy Smart Ankle-Foot Orthosis, 5-Azacitidine, Placebo - Cerebral Palsy | Phase 2 | Recruiting | Shirley Ryan AbilityLab | 60 | 2026-05-28 | 2026-06-01 |
| tSCS and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy tSCS, 5-Azacitidine, Mannitol - Cerebral Palsy | Phase 2 | Recruiting | Shirley Ryan AbilityLab | 80 | 2026-05-28 | 2026-05-29 |
| Pacritinib With Standard of Care Azacitidine or Decitabine as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant for Patients With Accelerated and Blast Phase Myeloproliferative Neoplasms Pacritinib, Decitabine, Decitabine and Cedazuridine - Accelerated Phase Myeloproliferative Neoplasm, Blast Phase Myeloproliferative Neoplasm | Phase 2 | Recruiting | University of Washington | 27 | 2026-03-02 | 2026-08-19 |
| Olutasidenib With Azacitidine Followed by Olutasidenib Maintenance for the Treatment of IDH1-mutated Acute Myeloid Leukemia in Patients With Prior Treatment With Venetoclax Plus a Hypomethylating Agent Azacitidine, Olutasidenib - Acute Myeloid Leukemia | Phase 2 | Recruiting | University of California, Davis | 28 | 2025-12-17 | 2026-10-27 |
| Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML Azacitidine, Biospecimen Collection, Bone Marrow Aspiration - Acute Monocytic Leukemia, Acute Myeloid Leukemia | Phase 2 | Recruiting | OHSU Knight Cancer Institute | 40 | 2025-01-03 | 2026-09-16 |
| Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial) Azacitidine, Biospecimen Collection, Bone Marrow Aspiration - Acute Myeloid Leukemia | Phase 2 | Recruiting | National Cancer Institute (NCI) | 147 | 2024-09-27 | 2026-10-28 |
| Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial) Azacitidine, Biospecimen Collection, Bone Marrow Aspiration - Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm | Phase 2 | Recruiting | National Cancer Institute (NCI) | 335 | 2024-09-25 | 2026-10-27 |
| Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial) Azacitidine, Biospecimen Collection, Bone Marrow Aspiration - Acute Myeloid Leukemia | Phase 2 | Recruiting | National Cancer Institute (NCI) | 153 | 2024-09-13 | 2026-10-28 |
| Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia Axatilimab, Azacitidine, Biospecimen Collection - Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia | Phase 1 / Phase 2 | Recruiting | Uma Borate | 49 | 2024-08-02 | 2026-08-27 |
| MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) Allogeneic Hematopoietic Stem Cell Transplantation, Azacitidine, Best Practice - Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm | Phase 2 | Recruiting | National Cancer Institute (NCI) | 2000 | 2024-06-18 | 2026-10-27 |
| Single Arm Study of Post-transplant Azacitidine and Chidamide for Prevention of Acute Myelogenous Leukemia Relapse Azacitidine, Chidamide - Leukemia, Myeloid, Acute | Phase 1 / Phase 2 | Recruiting | Zhujiang Hospital | 40 | 2022-02-01 | 2026-07-07 |
| BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia Azacitidine, Biopsy Procedure, Biospecimen Collection - Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome | Phase 2 | Active not recruiting | National Cancer Institute (NCI) | 60 | 2021-02-16 | 2026-08-03 |
| A Study of APG-115 Alone or Combined With Azacitidine in Patients With AML, CMML, or MDS APG-115, 5-azacitidine - AML, Acute Myeloid Leukemia | Phase 1 / Phase 2 | Unknown | Ascentage Pharma Group Inc. | 69 | 2020-12-04 | 2024-02-01 |
| Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) GSK3326595, 5-Azacitidine - Neoplasms | Phase 1 / Phase 2 | Terminated | GlaxoSmithKline | 30 | 2018-10-16 | 2023-02-06 |
| A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment 5-Azacitidine, all trans retinoic acid, Lupron - Prostatic Neoplasms, Prostate Neoplasms | Phase 2 | Completed | Icahn School of Medicine at Mount Sinai | 14 | 2018-08-20 | 2024-04-30 |
| Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma Durvalumab, Pralatrexate, Romidepsin - Lymphoma, T-Cell | Phase 1 / Phase 2 | Recruiting | University of Virginia | 148 | 2018-05-30 | 2022-03-31 |
| Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome Azacitidine, Cytarabine, Decitabine - Acute Myeloid Leukemia, Myelodysplastic Syndrome | Phase 2 / Phase 3 | Completed | National Cancer Institute (NCI) | 76 | 2018-02-02 | 2025-01-16 |
| Nivolumab With Chemotherapy in Refractory MDS Nivolumab, Azacitidine, Fludarabine - Myelodysplastic Syndromes | Phase 1 / Phase 2 | Terminated | St. Petersburg State Pavlov Medical University | 2 | 2017-05-25 | 2019-04-05 |
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Leukemia, Myeloid, Acute (19) · Myelodysplastic Syndromes (12) · Leukemia, Myelomonocytic, Chronic (6) · Leukemia (3) · Myeloproliferative Disorders (3) · Anemia, Refractory, with Excess of Blasts (2) · Cerebral Palsy (2) · GATA2 Deficiency (2) · Leukemia, Erythroblastic, Acute (2) · Leukemia, Megakaryoblastic, Acute (2) · Leukemia, Monocytic, Acute (2) · Anemia, Refractory (1) · Breast Neoplasms (1) · Breast Neoplasms, Male (1) · Burkitt Lymphoma (1)
National Cancer Institute (NCI) (13) · M.D. Anderson Cancer Center (3) · Shirley Ryan AbilityLab (2) · Ascentage Pharma Group Inc. (1) · GlaxoSmithKline (1) · Heinrich-Heine University, Duesseldorf (1) · Hetty Carraway (1) · Icahn School of Medicine at Mount Sinai (1) · OHSU Knight Cancer Institute (1) · St. Petersburg State Pavlov Medical University (1) · TetraLogic Pharmaceuticals (1) · Uma Borate (1) · University of California, Davis (1) · University of California, San Diego (1) · University of Utah (1)
United States (29) · Canada (7) · Puerto Rico (5) · Australia (1) · China (1) · Germany (1) · Russia (1)
Amer M Zeidan (1) · Anna Halpern, MD (1) · Arun Jayaraman, PhD (1) · Brian Jonas, MD (1) · Courtney DiNardo, MD (1) · Curtis A Lachowiez (1) · Edward D Ball, MD (1) · Ehab L Atallah (1) · Enrica Marchi, M.D., PhD (1) · Gautam Borthakur, MD (1) · Guido Kobbe, PD Dr. (1) · Guillermo Garcia-Manero, MD (1) · Hetty Carraway, MD (1) · Jerald P Radich (1)
PMID 24092933, PMID 24583822, PMID 27795561, PMID 29618479, PMID 36902217, PMID 38867582, PMID 39290981
U10CA180888 (4), U10CA180820 (3), U10CA032102 (2), N01CM00038 (1), N01CM00099 (1), N01CM17103 (1), N01CM62204 (1), N01CM62205 (1), P30CA006973 (1), P30CA013330 (1), P30CA093373 (1), U01CA070095 (1), U01CA099168 (1), U10CA180863 (1), U10CA180886 (1)