Search Cancer Clinical Trials
Recruiting
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-486 (ONUREG®) in combination with venetoclax in relapsed and/or refractory Acute Myeloid Leukemia (AML) and newly diagnosed AML.
- Leukemia, Myeloid, Acute
- CC-486
- Venetoclax
Phase 1
Interventional
Primary Outcome:
- Maximum Tolerated Dose (MTD)
- Incidence of type of adverse events (AEs)
- Incidence of frequency of AEs
- Incidence of severity of AEs
- Incidence of relationship of AEs to study treatment
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests
- Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Secondary Outcome:
- Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh)
- Overall Response Rate (ORR)
- Minimal Residual Disease (MRD) Response Rate
- MRD Conversion Rate
- Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi)
66
December 1, 2021
- Gender: All
- Minimum age: 18 Years
- Maximum age: N/A
- Healthy volunteers: No
Celgene
Celgene
A Phase 1B, Open-label, Global, Multicenter, Dose Determination Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of CC-486 (ONUREG®) in Combination Therapy in Subjects With Acute Myeloid Leukemia (AML)
NCT04887857
Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.