Back to resultsA Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML) (OMNIVERSE)
Primary Purpose
Leukemia, Myeloid, Acute
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CC-486
Venetoclax
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring Acute Myeloid Leukemia, CC-486, Onureg, oral azacitidine, venetoclax, Venclexta, Venclyxto
Eligibility 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
Sites / Locations
- Local Institution - 104
- Local Institution - 110
- Local Institution - 105
- Local Institution - 106
- Local Institution - 113
- Local Institution - 102
- Local Institution - 111
- Local Institution - 101
- Local Institution - 202
- Local Institution - 201
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CC-486 in combination with Venetoclax
Arm Description
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose (MTD)
Incidence of type of adverse events (AEs)
Incidence of frequency of AEs
Incidence of severity of AEs
Incidence of relationship of AEs to study treatment
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Secondary Outcome Measures
Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh)
Overall Response Rate (ORR)
Minimal Residual Disease (MRD) Response Rate
MRD Conversion Rate
Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04887857
Brief Title
A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)
Acronym
OMNIVERSE
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
June 24, 2024 (Anticipated)
Study Completion Date
April 18, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
Collaborators
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute
Keywords
Acute Myeloid Leukemia, CC-486, Onureg, oral azacitidine, venetoclax, Venclexta, Venclyxto
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CC-486 in combination with Venetoclax
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CC-486
Other Intervention Name(s)
ONUREG®, oral azacitidine
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
VENCLEXTA®, VENCLYXTO®
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD)
Time Frame
Up to 42 days after first dose
Title
Incidence of type of adverse events (AEs)
Time Frame
From informed consent form (ICF) signature to 28 days after last dose of study drug
Title
Incidence of frequency of AEs
Time Frame
From informed consent form (ICF) signature to 28 days after last dose of study drug
Title
Incidence of severity of AEs
Time Frame
From informed consent form (ICF) signature to 28 days after last dose of study drug
Title
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
Title
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
Title
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
Title
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 Measure Information:
Title
Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh)
Time Frame
Up to approximately 12 months
Title
Overall Response Rate (ORR)
Time Frame
Up to approximately 12 months
Title
Minimal Residual Disease (MRD) Response Rate
Time Frame
Up to approximately 12 months
Title
MRD Conversion Rate
Time Frame
Up to approximately 12 months
Title
Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi)
Time Frame
Up to approximately 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 104
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5317
Country
United States
Facility Name
Local Institution - 110
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Local Institution - 105
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Local Institution - 106
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Local Institution - 113
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Local Institution - 102
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Local Institution - 111
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Local Institution - 101
City
Houston
State/Province
Texas
ZIP/Postal Code
77003
Country
United States
Facility Name
Local Institution - 202
City
North Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Local Institution - 201
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)
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