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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04887857
Ethics application status
Date submitted
11/05/2021
Date registered
14/05/2021

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
NA
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04887857