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

February 9, 2024 updated by: Celgene

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia, 3004
        • Local Institution - 201
    • Victoria
      • North Melbourne, Victoria, Australia, 3002
        • Local Institution - 202
  • United States
    • California
      • Stanford, California, United States, 94305-5317
        • Local Institution - 104
    • Colorado
      • Denver, Colorado, United States, 80218
        • Local Institution - 110
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 105
    • New York
      • New York, New York, United States, 10029
        • Local Institution - 106
      • New York, New York, United States, 10065
        • Local Institution - 113
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 102
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Local Institution - 111
    • Texas
      • Houston, Texas, United States, 77003
        • Local Institution - 101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Tolerated Dose (MTD)
Time Frame: Up to 42 days after first dose
Up to 42 days after first dose
Incidence of type of adverse events (AEs)
Time Frame: From informed consent form (ICF) signature to 28 days after last dose of study drug
From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of frequency of AEs
Time Frame: From informed consent form (ICF) signature to 28 days after last dose of study drug
From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of severity of AEs
Time Frame: From informed consent form (ICF) signature to 28 days after last dose of study drug
From informed consent form (ICF) signature to 28 days after last dose of study drug
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
From informed consent form (ICF) signature to 28 days after last dose of study drug
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
From informed consent form (ICF) signature to 28 days after last dose of study drug
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
From informed consent form (ICF) signature to 28 days after last dose of study drug
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
From informed consent form (ICF) signature to 28 days after last dose of study drug

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh)
Time Frame: Up to approximately 12 months
Up to approximately 12 months
Overall Response Rate (ORR)
Time Frame: Up to approximately 12 months
Up to approximately 12 months
Minimal Residual Disease (MRD) Response Rate
Time Frame: Up to approximately 12 months
Up to approximately 12 months
MRD Conversion Rate
Time Frame: Up to approximately 12 months
Up to approximately 12 months
Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi)
Time Frame: Up to approximately 12 months
Up to approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Collaborators

AbbVie

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

January 8, 2024

Study Completion (Actual)

January 8, 2024

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-486-AML-004
  • 2020-004941-35 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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/

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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