1
Participants
Start Date
October 14, 2021
Primary Completion Date
March 9, 2022
Study Completion Date
March 9, 2022
CC-90011
CC-90011 will be given PO on Days 1, 8, and 15 of continuous 4-week (28-day) cycle. The dose escalation is designed to explore three dose levels of CC-90011, for example 20, 40, and 60 mg as determined by Bayesian design.
Venetoclax
Venetoclax is administered orally QD on Days 1 to 28 of each 28-day cycle with a brief dose ramp-up for Cycle 1 with the dosing of 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Day 3. Venetoclax should be administered at 400 mg on subsequent days.
Azacitidine
Azacitidine is administered on Days 1 to 7 of each 28-day cycle as an IV infusion or SC injection at 75 mg/m2
Venetoclax
Venetoclax is administered orally QD on Days 1 to 28 of each 28-day cycle
CC-90011
CC-90011 will be given PO on Days 1, 8, and 15 of continuous 4-week (28-day) cycle at the recommended phase to dose of CC-90011 confirmed in dose escalation.
Local Institution - 202, Ghent
Local Institution - 121, New York
Local Institution - 118, Durham
Local Institution - 802, Madrid
Local Institution - 108, Miami
Local Institution - 801, Seville
Local Institution - 115, Columbus
Local Institution - 116, Cleveland
Local Institution - 111, Chicago
Local Institution - 104, Dallas
Local Institution - 101, Houston
Local Institution - 401, Villejuif
Local Institution - 120, Seattle
Local Institution - 110, Duarte
Local Institution - 103, New Haven
Local Institution - 803, Barcelona
Local Institution - 800, Barcelona
Lead Sponsor
Celgene
INDUSTRY