23 completed, 7 active not recruiting, 7 terminated, 2 recruiting. 22 Phase 2, 18 Phase 1, 6 Phase 3.
Follow cc-486: new trials by email Literature Review of cc-486 trials Research Report on cc-486
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 |
|---|---|---|---|---|---|---|
| A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies Onureg - Hepatic Insufficiency, Neoplasms | Phase 1 | Terminated | Bristol-Myers Squibb | 2 | 2024-07-12 | 2026-01-12 |
| Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia AzaCITIDine Oral Tablet, Xospata - AML, Adult, Refractory AML | Phase 2 | Recruiting | French Innovative Leukemia Organisation | 33 | 2024-01-13 | 2025-03-24 |
| Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes Onureg + Venetoclax - Untreated Myelodysplastic Syndrome | Phase 1 / Phase 2 | Active not recruiting | Groupe Francophone des Myelodysplasies | 36 | 2023-12-06 | 2026-08-11 |
| Oral Azacitidine (CC-486) Epigenetic Priming and Maintenance for Adult Acute Myeloid Leukemia (AML) Patients oral azacitidine (CC-486) - Acute Myeloid Leukemia | Phase 2 | Withdrawn | Yale University | 2023-11-01 | 2023-12-26 | |
| CC-486 and Venetoclax for Acute Myeloid Leukemia Venetoclax, CC-486 - AML | Phase 1 | Recruiting | University of Colorado, Denver | 35 | 2022-12-19 | 2026-01-15 |
| Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma CC-486 (5-azacitidine), Duvelisib, Romidepsin - Adult T-cell Leukemia/Lymphoma, Extranodal NK-/T-cell Lymphoma, Nasal Type | Phase 1 | Withdrawn | National Cancer Institute (NCI) | 2022-11-03 | 2022-11-04 | |
| An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission CC-486, Placebo - Leukemia, Myeloid, Acute | Phase 2 | Active not recruiting | Bristol-Myers Squibb | 34 | 2022-08-19 | 2026-04-28 |
| Oral Azacitidine for the Treatment of Relapsed or Refractory T-cell Large Granular Lymphocytic Leukemia Oral Azacitidine - T-Cell Large Granular Lymphocyte Leukemia | Phase 1 / Phase 2 | Active not recruiting | Jonathan Brammer | 11 | 2022-06-29 | 2026-10-21 |
| A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission Oral Azacitidine, Placebo - Acute Myeloid Leukemia | Phase 2 | Active not recruiting | Bristol-Myers Squibb | 19 | 2022-01-17 | 2026-02-11 |
| CC-486 and Nivolumab for the Treatment of Hodgkin Lymphoma Refractory to PD-1 Therapy or Relapsed Nivolumab, Oral Azacitidine - Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma | Phase 1 | Active not recruiting | City of Hope Medical Center | 33 | 2022-01-03 | 2026-06-03 |
| A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML) CC-486, Venetoclax - Leukemia, Myeloid, Acute | Phase 1 | Completed | Celgene | 6 | 2021-12-01 | 2024-02-12 |
| A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma Venetoclax, Obinutuzumab, CC-486 - Follicular Lymphoma | Phase 1 / Phase 2 | Terminated | University of Chicago | 2 | 2021-09-01 | 2024-05-16 |
| Study of Magrolimab Combinations in Participants With Myeloid Malignancies Magrolimab, Azacitidine, Venetoclax - Myeloid Malignancies | Phase 2 | Terminated | Gilead Sciences | 54 | 2021-06-28 | 2025-03-20 |
| Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma Biospecimen Collection, Computed Tomography, Cyclophosphamide - Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IIX (Bulky) Diffuse Large B-Cell Lymphoma | Phase 2 / Phase 3 | Active not recruiting | National Cancer Institute (NCI) | 422 | 2021-05-20 | 2026-10-01 |
| Pilot Study of CC 486 (Oral Azacitidine) Plus BSC as Maintenance After sc Azacitidine in Elderly HR-IPSS-R MDS Patients CC-486 - MDS, CMML | Phase 2 | Completed | University of Florence | 11 | 2021-03-24 | 2026-05-06 |
| Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies Romidepsin, Lenalidomide, CC-486 (5-azacitidine) - Cutaneous T-Cell Lymphoma, Mature T-cell Malignancies | Phase 1 | Completed | National Cancer Institute (NCI) | 26 | 2020-12-17 | 2026-10-14 |
| CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma Lenalidomide, Obinutuzumab, Oral Azacitidine - Indolent B-Cell Non-Hodgkin Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma | Phase 1 | Completed | Joseph Tuscano | 8 | 2020-10-23 | 2025-04-24 |
| A Study of Lenalidomide and CC-486 With Radiation Therapy in Patients With Plasmacytoma CC-486, Lenalidomide, Radiation Therapy - Plasmacytoma, Plasmacytoma of Bone | Phase 2 | Active not recruiting | Memorial Sloan Kettering Cancer Center | 21 | 2019-11-19 | 2025-12-02 |
| Randomised Study of Oral Azacitidine vs Placebo Maintenance in AML or MDS Patients After Allo-SCT Oral azacitidine, Matched placebo - Acute Myeloid Leukemia, Myelodysplasia | Phase 3 | Completed | University of Birmingham | 326 | 2019-06-14 | 2026-08-14 |
| Oral Azacitidine Plus Salvage Chemotherapy in Relapsed/Refractory Diffuse Large B Cell Lymphoma Oral azacitidine, R-ICE - Large B-Cell Diffuse Lymphoma | Phase 1 | Completed | Medical University of South Carolina | 9 | 2019-04-04 | 2024-10-28 |
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Leukemia, Myeloid, Acute (13) · Myelodysplastic Syndromes (7) · Neoplasms (5) · Carcinoma, Non-Small-Cell Lung (4) · Hematologic Neoplasms (3) · Leukemia, Myelomonocytic, Chronic (3) · Lymphoma, Follicular (3) · Lymphoma, Large B-Cell, Diffuse (3) · Multiple Myeloma (3) · Breast Neoplasms (2) · Hodgkin Disease (2) · Lung Neoplasms (2) · Lymphoma (2) · Lymphoma, B-Cell, Marginal Zone (2) · Lymphoma, Non-Hodgkin (2)
Celgene (16) · Bristol-Myers Squibb (3) · National Cancer Institute (NCI) (3) · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (2) · Celgene Corporation (1) · City of Hope Medical Center (1) · French Innovative Leukemia Organisation (1) · Gilead Sciences (1) · Groupe Francophone des Myelodysplasies (1) · Jonathan Brammer (1) · Joseph Tuscano (1) · Kirby Institute (1) · Medical University of South Carolina (1) · Memorial Sloan Kettering Cancer Center (1) · The Lymphoma Academic Research Organisation (1)
United States (32) · France (11) · Spain (9) · United Kingdom (9) · Italy (8) · Germany (7) · Australia (6) · Canada (6) · Belgium (5) · Greece (3) · Japan (3) · Poland (3) · Austria (2) · Brazil (2) · Czechia (2)
Barry Skikne, M.D., FACP; FCP (SA) (2) · Nilofer Azad, MD (2) · Brian Hess, MD (1) · Charles Craddock (1) · Daniel E Pollyea, MD (1) · Du Lam, MD (1) · Elizabeth A Brem (1) · Gordan Bray, M.D., Ph.D (1) · Ileana Elias, MD (1)
PMID 38796193, PMID 26296092, PMID 29764853, PMID 29933073, PMID 32753546, PMID 33369355, PMID 33643895, PMID 33764805, PMID 34428285, PMID 34454540, PMID 34686472, PMID 34995344, PMID 35437111, PMID 35960871, PMID 36463226, PMID 36951156, PMID 37952982, PMID 39863139, PMID 40364806, PMID 41779512, PMID 42498285
2014 (3), 2023 (1), P30CA033572 (1), P30CA093373 (1), T32CA233414 (1), U10CA180888 (1)