CC-486 and Venetoclax for Acute Myeloid Leukemia
This study is testing a combination of two drugs, CC-486 (an oral form of azacitidine) and Venetoclax, for people with Acute Myeloid Leukemia (AML). The main goal is to find the highest safe dose of CC-486 when given with Venetoclax. You might be able to join if you are 18 to 100 years old and have AML. This includes people whose AML has come back or didn't respond to previous treatment, or those newly diagnosed. The study aims to determine the maximum tolerated dose of CC-486 in combination with venetoclax over 7 years. The current recruitment status is unclear.
- Study design
- This is an open-label, single-institution pilot study with a planned enrollment of 35 participants. It involves increasing the dose of CC-486 to find the safest and most effective amount.
- What's involved
- You will be admitted to the hospital for the first cycle. You will receive Venetoclax daily and CC-486 orally for 14 days of a 28-day cycle. You will have bone marrow biopsies at specific times during and after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint to determine the maximum tolerated dose is measured at 7 years, suggesting a long-term follow-up period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CC-486 and Venetoclax for Acute Myeloid Leukemia
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Daniel E Pollyea, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
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What this trial measures
- Determine the maximum tolerated dose of CC-486 in combination with venetoclax7 years
Standard phase I 3+3 design. The first 3 subjects will be assigned to cohort 1. If none of the first three subjects' experiences DLT, escalation to cohort 2 is permitted. If one of the first three subjects' experiences DLT, a total of six subjects will be required in that dose cohort, and escalation will only be permitted if five of six subjects do not experience DLT. If more than one DLT is observed in the second cohort, this will be determined to be the maximally administered dose, and three more subjects will be enrolled in the first cohort if only three were previously treated at that dose. The MTD will be the cohort in which ≤1/6 subjects have dose limiting toxicity at the dose prior to the maximally administered dose. If the second cohort has ≤1/6 subjects with a DLT, the MTD will not have been reached, and the recommended dose for the expansion cohorts will be determined based on the safety, efficacy and pharmacodynamic outcomes from subjects treated in the first two cohorts.