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

PHASE1TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

October 14, 2021

Primary Completion Date

March 9, 2022

Study Completion Date

March 9, 2022

Conditions
Leukemia, Myeloid
Interventions
DRUG

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.

DRUG

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.

DRUG

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

DRUG

Venetoclax

Venetoclax is administered orally QD on Days 1 to 28 of each 28-day cycle

DRUG

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.

Trial Locations (17)

9000

Local Institution - 202, Ghent

10029

Local Institution - 121, New York

27710

Local Institution - 118, Durham

28007

Local Institution - 802, Madrid

33136

Local Institution - 108, Miami

41013

Local Institution - 801, Seville

43210

Local Institution - 115, Columbus

44195

Local Institution - 116, Cleveland

60611

Local Institution - 111, Chicago

75246

Local Institution - 104, Dallas

77030

Local Institution - 101, Houston

94805

Local Institution - 401, Villejuif

98104

Local Institution - 120, Seattle

91010-301

Local Institution - 110, Duarte

06510

Local Institution - 103, New Haven

08035

Local Institution - 803, Barcelona

08907

Local Institution - 800, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY