drugset / Trial / NCT04748848
A Safety, Tolerability and Preliminary Efficacy Study of CC-90011 in Combination With Venetoclax and Azacitidine in R/R Acute Myeloid Leukemia and Treatment-naïve Participants Not Eligible for Intensive Therapy
RandomizedSequentialOpen-labelTreatment
Summary
CC-90011-AML-002 is a Phase 1/2, open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently with Venetoclax and Azacitidine. This study will include 3 parts: a dose escalation part in R/R AML, a dose escalation part in ndAML (treatment-naïve participants with AML who are ≥ 75 years of age or are ≥ 18 to 74 years of age and otherwise not eligible for intensive induction chemotherapy), and a randomized dose expansion part in ndAML of Venetoclax and Azacitidine with or without CC-90011.
Timeline
- Start
- 2021-10-14
- Primary completion
- 2022-03-09
- Completion
- 2022-03-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CC-90011 | Small molecule | 20 mg | Oral |
| Subject | CC-90011 | Small molecule | 40 mg | Oral |
| Subject | CC-90011 | Small molecule | 60 mg | Oral |
| Background | Azacitidine | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Venetoclax | Small molecule | 400 mg | Oral |