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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04887857




Registration number
NCT04887857
Ethics application status
Date submitted
11/05/2021
Date registered
14/05/2021
Date last updated
12/02/2024

Titles & IDs
Public title
A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)
Scientific 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)
Secondary ID [1] 0 0
2020-004941-35
Secondary ID [2] 0 0
CC-486-AML-004
Universal Trial Number (UTN)
Trial acronym
OMNIVERSE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - CC-486
Treatment: Drugs - Venetoclax

Experimental: CC-486 in combination with Venetoclax -


Treatment: Drugs: CC-486
Specified dose on specified days

Treatment: Drugs: Venetoclax
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose (MTD)
Timepoint [1] 0 0
Up to 42 days after first dose
Primary outcome [2] 0 0
Incidence of type of adverse events (AEs)
Timepoint [2] 0 0
From informed consent form (ICF) signature to 28 days after last dose of study drug
Primary outcome [3] 0 0
Incidence of frequency of AEs
Timepoint [3] 0 0
From informed consent form (ICF) signature to 28 days after last dose of study drug
Primary outcome [4] 0 0
Incidence of severity of AEs
Timepoint [4] 0 0
From informed consent form (ICF) signature to 28 days after last dose of study drug
Primary outcome [5] 0 0
Incidence of relationship of AEs to study treatment
Timepoint [5] 0 0
From informed consent form (ICF) signature to 28 days after last dose of study drug
Primary outcome [6] 0 0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Timepoint [6] 0 0
From informed consent form (ICF) signature to 28 days after last dose of study drug
Primary outcome [7] 0 0
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Timepoint [7] 0 0
From informed consent form (ICF) signature to 28 days after last dose of study drug
Primary outcome [8] 0 0
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Timepoint [8] 0 0
From informed consent form (ICF) signature to 28 days after last dose of study drug
Secondary outcome [1] 0 0
Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh)
Timepoint [1] 0 0
Up to approximately 12 months
Secondary outcome [2] 0 0
Overall Response Rate (ORR)
Timepoint [2] 0 0
Up to approximately 12 months
Secondary outcome [3] 0 0
Minimal Residual Disease (MRD) Response Rate
Timepoint [3] 0 0
Up to approximately 12 months
Secondary outcome [4] 0 0
MRD Conversion Rate
Timepoint [4] 0 0
Up to approximately 12 months
Secondary outcome [5] 0 0
Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi)
Timepoint [5] 0 0
Up to approximately 12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/01/2024
Sample size
Target
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - 202 - North Melbourne
Recruitment hospital [2] 0 0
Local Institution - 201 - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - North Melbourne
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celgene
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
AbbVie
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04887857
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04887857