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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)

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ClinicalTrials.gov Identifier: NCT04887857
Recruitment Status : Recruiting
First Posted : May 14, 2021
Last Update Posted : May 18, 2022
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Celgene

Study Description
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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
Leukemia, Myeloid, Acute Drug: CC-486 Drug: Venetoclax Phase 1

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 1, 2021
Estimated Primary Completion Date : April 29, 2024
Estimated Study Completion Date : March 17, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CC-486 in combination with Venetoclax Drug: CC-486
Specified dose on specified days
Other Name: ONUREG®, oral azacitidine

Drug: Venetoclax
Specified dose on specified days
Other Name: VENCLEXTA®, VENCLYXTO®


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

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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04887857


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT # and Site #.

Locations
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United States, California
Stanford University Not yet recruiting
Stanford, California, United States, 94305-5317
United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
United States, Massachusetts
Massachusetts General Hospital / Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02114
United States, New York
Icahn School of Medicine at Mount Sinai Not yet recruiting
New York, New York, United States, 10029
Cornell University Weill Medical College Not yet recruiting
New York, New York, United States, 10065
United States, Ohio
Cleveland Clinic Foundation Not yet recruiting
Cleveland, Ohio, United States, 44195
United States, Oklahoma
University of Oklahoma Peggy and Charles Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77003
Australia
Alfred Hospital Recruiting
Melbourne, Australia, 3004
Sponsors and Collaborators
Celgene
AbbVie
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04887857    
Other Study ID Numbers: CC-486-AML-004
2020-004941-35 ( EudraCT Number )
First Posted: May 14, 2021    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
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/

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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:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Azacitidine
Venetoclax
 Cc-486
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors