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

Sponsor
Celgene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04887857
Collaborator
AbbVie (Industry)
66
9
1
51.5
7.3
0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1B, Open-label, Global, Multicenter, Dose Determination Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of CC-486 (ONUREG®) in Combination Therapy in Subjects With Acute Myeloid Leukemia (AML)
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Apr 29, 2024
Anticipated Study Completion Date :
Mar 17, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: CC-486 in combination with Venetoclax

Drug: CC-486
Specified dose on specified days
Other Names:
  • ONUREG®, oral azacitidine
  • Drug: Venetoclax
    Specified dose on specified days
    Other Names:
  • VENCLEXTA®, VENCLYXTO®
  • Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose (MTD) [Up to 42 days after first dose]

    2. Incidence of type of adverse events (AEs) [From informed consent form (ICF) signature to 28 days after last dose of study drug]

    3. Incidence of frequency of AEs [From informed consent form (ICF) signature to 28 days after last dose of study drug]

    4. Incidence of severity of AEs [From informed consent form (ICF) signature to 28 days after last dose of study drug]

    5. Incidence of relationship of AEs to study treatment [From informed consent form (ICF) signature to 28 days after last dose of study drug]

    6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [From informed consent form (ICF) signature to 28 days after last dose of study drug]

    7. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [From informed consent form (ICF) signature to 28 days after last dose of study drug]

    8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [From informed consent form (ICF) signature to 28 days after last dose of study drug]

    Secondary Outcome Measures

    1. Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh) [Up to approximately 12 months]

    2. Overall Response Rate (ORR) [Up to approximately 12 months]

    3. Minimal Residual Disease (MRD) Response Rate [Up to approximately 12 months]

    4. MRD Conversion Rate [Up to approximately 12 months]

    5. Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi) [Up to approximately 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Confirmation of the following for Acute Myeloid Leukemia (AML)

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. ECOG 3 is allowed if participants are 18 to 74 years old with comorbidities

    • Agree to serial bone marrow aspirate/biopsies

    Exclusion Criteria:
    • Suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype

    • Received prior hypomethylating agent (HMA) therapy for myelodysplastic syndromes/Chronic myelomonocytic leukemia then develop AML within 4 months of discontinuing the HMA therapy

    • Prior history of malignancy unless the participant has been free of the disease for ≥ 1 year prior to the start of study treatment

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Stanford California United States 94305-5317
    2 Colorado Blood Cancer Institute Denver Colorado United States 80218
    3 Massachusetts General Hospital / Dana-Farber Cancer Institute Boston Massachusetts United States 02114
    4 Icahn School of Medicine at Mount Sinai New York New York United States 10029
    5 Cornell University Weill Medical College New York New York United States 10065
    6 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    7 University of Oklahoma Peggy and Charles Stephenson Cancer Center Oklahoma City Oklahoma United States 73104
    8 MD Anderson Cancer Center Houston Texas United States 77003
    9 Alfred Hospital Melbourne Australia 3004

    Sponsors and Collaborators

    • Celgene
    • AbbVie

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT04887857
    Other Study ID Numbers:
    • CC-486-AML-004
    • 2020-004941-35
    First Posted:
    May 14, 2021
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Celgene
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 18, 2022