A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)

Part of paid clinical trials in Stanford, California.

Sponsor
Celgene
Study ID
NCT04887857
Phase
PHASE1
Status
Completed

Conditions

  • Leukemia, Myeloid, Acute

Eligibility Criteria

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

Interventions

  • CC-486 — DRUG
    Specified dose on specified days
  • Venetoclax — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-486 (ONUREG®) in combination with venetoclax in relapsed and/or refractory Acute Myeloid Leukemia (AML) and newly diagnosed AML.

Key Dates

Start date
Dec 1, 2021
Status verified
Feb 2024
Primary completion
Jan 8, 2024
Completion
Jan 8, 2024

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CC-486 in combination with Venetoclax

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Up to 42 days after first dose ]

Locations (8)

FacilityCityStateZIPSite coordinators
Local Institution - 104StanfordCalifornia94305-5317-
Local Institution - 110DenverColorado80218-
Local Institution - 105BostonMassachusetts02114-
Local Institution - 106New YorkNew York10029-
Local Institution - 113New YorkNew York10065-
Local Institution - 102ClevelandOhio44195-
Local Institution - 111Oklahoma CityOklahoma73104-
Local Institution - 101HoustonTexas77003-

Find similar trials in Stanford, CA

By research site
Local Institution - 104· Stanford, CALocal Institution - 110· Denver, COLocal Institution - 105· Boston, MALocal Institution - 106· New York, NYLocal Institution - 113· New York, NYLocal Institution - 102· Cleveland, OH

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