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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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

  • Clinicaltrials.gov identifier

    NCT04887857

  • Recruitment Status

    Recruiting

  • First Posted

    May 14, 2021

  • Last update posted

    November 23, 2021

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:Leukemia, Myeloid, Acute
  • Intervention/Treatment: Drug: CC-486
    Drug: Venetoclax
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 36 participants
  • 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)
  • Estimated Study Start Date: November 2021
  • Estimated Primary Completion Date: June 2024
  • Estimated Study Completion Date: February 2026

Arms and interventions

Arm Intervention/treatment
Experimental: CC-486 in combination with Venetoclax
Drug: CC-486
Specified dose on specified days

Drug: Venetoclax
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Maximum Tolerated Dose (MTD) [ Time Frame: Up to 42 days after first dose ]
  • 2. Incidence of type of adverse events (AEs) [ Time Frame: From informed consent form (ICF) signature to 28 days after last dose of study drug ]
  • 3. Incidence of frequency of AEs [ Time Frame: From informed consent form (ICF) signature to 28 days after last dose of study drug ]
  • 4. Incidence of severity of AEs [ Time Frame: From informed consent form (ICF) signature to 28 days after last dose of study drug ]
  • 5. Incidence of relationship of AEs to study treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Up to approximately 12 months ]
  • 2. Overall Response Rate (ORR) [ Time Frame: Up to approximately 12 months ]
  • 3. Minimal Residual Disease (MRD) Response Rate [ Time Frame: Up to approximately 12 months ]
  • 4. MRD Conversion Rate [ Time Frame: Up to approximately 12 months ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com 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 subject 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

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT # and Site #.

Locations

United States, California
Stanford University
Stanford

United States, Colorado
Colorado Blood Cancer Institute
Denver

United States, Massachusetts
Massachusetts General Hospital / Dana-Farber Cancer Institute
Boston

United States, New York
Icahn School of Medicine at Mount Sinai
New York

United States, New York
Cornell University Weill Medical College
New York

United States, Ohio
Cleveland Clinic Foundation
Cleveland

United States, Oklahoma
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City

United States, Texas
MD Anderson Cancer Center
Houston

Australia
Alfred Hospital
Melbourne

Sponsors and Collaborators

Celgene

AbbVie

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT04887857 History of Changes
  • Other Study ID Numbers: CC-486-AML-004, 2020-004941-35
  • First Posted: May 14, 2021 Key Record Dates
  • Last Update Posted: November 23, 2021
  • Last Verified: November 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: See Plan Description
  • Access Criteria: See Plan Description
  • URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Acute Myeloid Leukemia
    CC-486
    Onureg
    oral azacitidine
    venetoclax
    Venclexta
    Venclyxto
  • Additional relevant MeSH terms: Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Neoplasms by Histologic Type
    Neoplasms