Clinical trial NCT04887857: A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia, Myeloid, Acute
Keywords: Acute Myeloid Leukemia
CC-486
Onureg
oral azacitidine
venetoclax
Venclexta
Venclyxto
Lead sponsor: Celgene
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2021-05-14
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: Up to 42 days after first dose
measure: Incidence of type of adverse events (AEs)
timeFrame: From informed consent form (ICF) signature to 28 days after last dose of study drug
measure: Incidence of frequency of AEs
timeFrame: From informed consent form (ICF) signature to 28 days after last dose of study drug
measure: Incidence of severity of AEs
timeFrame: From informed consent form (ICF) signature to 28 days after last dose of study drug
measure: Incidence of relationship of AEs to study treatment
timeFrame: From informed consent form (ICF) signature to 28 days after last dose of study drug
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: From informed consent form (ICF) signature to 28 days after last dose of study drug
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
timeFrame: From informed consent form (ICF) signature to 28 days after last dose of study drug
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: From informed consent form (ICF) signature to 28 days after last dose of study drug
Secondary outcomes:
measure: Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh)
timeFrame: Up to approximately 12 months
measure: Overall Response Rate (ORR)
timeFrame: Up to approximately 12 months
measure: Minimal Residual Disease (MRD) Response Rate
timeFrame: Up to approximately 12 months
measure: MRD Conversion Rate
timeFrame: Up to approximately 12 months
measure: Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi)
timeFrame: Up to approximately 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Local Institution - 104
state: California
city: Denver
country: United States
facility: Local Institution - 110
state: Colorado
city: Boston
country: United States
facility: Local Institution - 105
state: Massachusetts
city: New York
country: United States
facility: Local Institution - 106
state: New York
city: New York
country: United States
facility: Local Institution - 113
state: New York
city: Cleveland
country: United States
facility: Local Institution - 102
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution - 111
state: Oklahoma
city: Houston
country: United States
facility: Local Institution - 101
state: Texas
city: North Melbourne
country: Australia
facility: Local Institution - 202
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 201
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: