A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia

Part of paid clinical trials in San Francisco, California.

Sponsor
Celgene
Study ID
NCT04336982
Phase
PHASE1
Status
Terminated

Conditions

  • Leukemia, Myeloid, Acute

Eligibility Criteria

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

Interventions

  • CC-90009 — DRUG
    Injection
  • Venetoclax — DRUG
    Tablet
  • Azacitidine — DRUG
    Injection
  • Gilteritinib — DRUG
    Tablet

Study Details

CC-90009-AML-002 is an exploratory Phase 1b, open-label, multi-arm trial to evaluate the safety and efficacy of CC-90009 in combination with anti-leukemia agents in participants with acute myeloid leukemia (AML).

Key Dates

Start date
Aug 5, 2020
Status verified
May 2024
Primary completion
Oct 25, 2023
Completion
Apr 5, 2024

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CC-90009 in combination with venetoclax and azacitidine
    CC-90009 will be administered intravenously per dosing schedule in a 28-day cycle. Venetoclax will be administered orally QD. Azacitidine will be administered intravenously or subcutaneously on planned dosing days for each cycle.
  • Experimental: CC-90009 in combination with gilteritinib
    CC-90009 will be administered intravenously per dosing schedule in a 28-day cycle. Gilteritinib will be administered orally QD.

Primary Outcome Measure

Dose Limiting Toxicity (DLT) [ Time Frame: Up to 28 days ]

Locations (7)

FacilityCityStateZIPSite coordinators
Local Institution - 104San FranciscoCalifornia94143-0324-
Local Institution - 107New HavenConnecticut06510-
Local Institution - 103BostonMassachusetts02115-
Local Institution - 101St LouisMissouri63110-
Local Institution - 108HackensackNew Jersey07601-
Local Institution - 105HoustonTexas77030-4009-
Local Institution - 102SeattleWashington98109-1024-

Find similar trials in San Francisco, CA

By research site
Local Institution - 104· San Francisco, CALocal Institution - 107· New Haven, CTLocal Institution - 103· Boston, MALocal Institution - 101· St Louis, MOLocal Institution - 108· Hackensack, NJLocal Institution - 105· Houston, TX

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