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

Part of paid clinical trials in Duarte, California.

Sponsor
Celgene
Study ID
NCT04748848
Phase
PHASE1
Status
Terminated

Conditions

  • Leukemia, Myeloid

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CC-90011 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    Venetoclax is administered orally QD on Days 1 to 28 of each 28-day cycle
  • CC-90011 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 14, 2021
Status verified
Feb 2023
Primary completion
Mar 9, 2022
Completion
Mar 9, 2022

Study Design

Enrollment
1 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CC-90011 in combination with Venetoclax and Azacitidine in Dose Escalation
    CC-90011 in combination with venetoclax and azacitidine in dose escalation
  • Experimental: Venetoclax and Azacitidine
    Venetoclax and Azacitidine control arm in dose expansion. The participants will be randomized to the treatment arm or control arm at a 2:1 ratio.
  • Experimental: CC-90011 in combination with Venetoclax and Azacitidine in Dose Expansion
    CC-90011 in combination with venetoclax and azacitidine in dose expansion

Primary Outcome Measure

Adverse Events (AEs) [ Time Frame: From ICF signature until 28 days after last dose of CC- 90011 and all combination agents ]

Locations (11)

FacilityCityStateZIPSite coordinators
Local Institution - 110DuarteCalifornia91010-301-
Local Institution - 103New HavenConnecticut06510-
Local Institution - 108MiamiFlorida33136-
Local Institution - 111ChicagoIllinois60611-
Local Institution - 121New YorkNew York10029-
Local Institution - 118DurhamNorth Carolina27710-
Local Institution - 116ClevelandOhio44195-
Local Institution - 115ColumbusOhio43210-
Local Institution - 104DallasTexas75246-
Local Institution - 101HoustonTexas77030-
Local Institution - 120SeattleWashington98104-

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Local Institution - 110· Duarte, CALocal Institution - 103· New Haven, CTLocal Institution - 108· Miami, FLLocal Institution - 111· Chicago, ILLocal Institution - 121· New York, NYLocal Institution - 118· Durham, NC

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