Leukemia, Myeloid, AcutePhase 1OMNIVERSENCT04887857
A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)
A Phase 1 study testing CC-486 and Venetoclax in people with Leukemia, Myeloid, Acute, run by Celgene at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- CC-486 and Venetoclax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 1 Dec 2021to 8 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
Local Institution - 105
Boston, Massachusetts, 02114
Local Institution - 102
Cleveland, Ohio, 44195
Local Institution - 110
Denver, Colorado, 80218
Local Institution - 101
Houston, Texas, 77003
Local Institution - 106
New York, New York, 10029
Local Institution - 113
New York, New York, 10065
Local Institution - 111
Oklahoma City, Oklahoma, 73104
Local Institution - 104
Stanford, California, 94305-5317
Australia2 sites
Local Institution - 201
Melbourne, 3004
Local Institution - 202
North Melbourne, Victoria, 3002
About this study
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)
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.
- Conditions
- Leukemia, Myeloid, Acute
- Being tested
- CC-486, Venetoclax
- Keywords
- Acute Myeloid Leukemia, CC-486, Onureg, oral azacitidine, venetoclax, Venclexta, Venclyxto
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-486Drug
Also called ONUREG®, oral azacitidine
Specified dose on specified days
VenetoclaxDrug
Also called VENCLEXTA®, VENCLYXTO®
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| CC-486 in combination with Venetoclax | Experimental | Not described Receives: Drug: CC-486; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Measured: Up to 42 days after first dose
Incidence of type of adverse events (AEs)
Measured: From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of frequency of AEs
Measured: From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of severity of AEs
Measured: From informed consent form (ICF) signature to 28 days after last dose of study drug
Incidence of relationship of AEs to study treatment
Measured: 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
Measured: 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
Measured: 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
Measured: From informed consent form (ICF) signature to 28 days after last dose of study drug
Secondary outcomes (5)
Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh)
Measured: Up to approximately 12 months
Overall Response Rate (ORR)
Measured: Up to approximately 12 months
Minimal Residual Disease (MRD) Response Rate
Measured: Up to approximately 12 months
MRD Conversion Rate
Measured: Up to approximately 12 months
Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi)
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 Dec 2021
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887857
- Sponsor's protocol ID
- CC-486-AML-004
- Other IDs
- 2020-004941-35
- Acronym
- OMNIVERSE
- Status last verified
- Feb 2024
- First submitted
- 11 May 2021
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04887857
- Acronym / sponsor ID
- OMNIVERSE / CC-486-AML-004
- Conditions
- Leukemia, Myeloid, Acute
- Keywords
- Acute Myeloid Leukemia, CC-486, Onureg, oral azacitidine, venetoclax, Venclexta, Venclyxto
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CC-486 in combination with Venetoclax | Experimental | Drug: CC-486, Drug: Venetoclax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-486Also: ONUREG®, oral azacitidineSpecified dose on specified days | Drug | CC-486 in combination with Venetoclax |
| VenetoclaxAlso: VENCLEXTA®, VENCLYXTO®Specified dose on specified days | Drug | CC-486 in combination with Venetoclax |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 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
Incidence of frequency of AEs
Time frame: 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
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
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
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
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
5 secondary outcomes
Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh)
Time frame: Up to approximately 12 months
Overall Response Rate (ORR)
Time frame: Up to approximately 12 months
Minimal Residual Disease (MRD) Response Rate
Time frame: Up to approximately 12 months
MRD Conversion Rate
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-486 and Venetoclax in people with Leukemia, Myeloid, Acute, run by Celgene at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: Up to 42 days after first dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.