A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)

NCT04887857 | Completed Phase 1 FDA Drug

• 2 other identifiers: CC-486-AML-0042020-004941-35
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 10

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.

Conditions

Leukemia, Myeloid, Acute

Keywords

Acute Myeloid Leukemia; CC-486; Onureg; oral azacitidine; venetoclax; Venclexta; Venclyxto

Outcome Measures

Primary Outcomes (8)

• Maximum Tolerated Dose (MTD)

  Up to 42 days after first dose

• Incidence of type of adverse events (AEs)

  From informed consent form (ICF) signature to 28 days after last dose of study drug

• Incidence of frequency of AEs

  From informed consent form (ICF) signature to 28 days after last dose of study drug

• Incidence of severity of AEs

  From informed consent form (ICF) signature to 28 days after last dose of study drug

• Incidence of relationship of AEs to study treatment

  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

  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

  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

  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)

  Up to approximately 12 months

• Overall Response Rate (ORR)

  Up to approximately 12 months

• Minimal Residual Disease (MRD) Response Rate

  Up to approximately 12 months

• MRD Conversion Rate

  Up to approximately 12 months

• Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi)

  Up to approximately 12 months

Study Arms (1)

CC-486 in combination with Venetoclax

EXPERIMENTAL

Drug: CC-486; Drug: Venetoclax

Interventions

CC-486 DRUG

Specified dose on specified days

Also known as: ONUREG®, oral azacitidine

CC-486 in combination with Venetoclax

Venetoclax DRUG

Specified dose on specified days

Also known as: VENCLEXTA®, VENCLYXTO®

CC-486 in combination with Venetoclax

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene: lead
• AbbVie: collaborator

Study Sites (10)

Local Institution - 104

Stanford, California, 94305-5317, United States

Location

Local Institution - 110

Denver, Colorado, 80218, United States

Location

Local Institution - 105

Boston, Massachusetts, 02114, United States

Location

Local Institution - 106

New York, New York, 10029, United States

Location

Local Institution - 113

New York, New York, 10065, United States

Location

Local Institution - 102

Cleveland, Ohio, 44195, United States

Location

Local Institution - 111

Oklahoma City, Oklahoma, 73104, United States

Location

Local Institution - 101

Houston, Texas, 77003, United States

Location

Local Institution - 202

North Melbourne, Victoria, 3002, Australia

Location

Local Institution - 201

Melbourne, 3004, Australia

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

cc-486; Azacitidine; venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 14, 2021
• Study Start: December 1, 2021
• Primary Completion: January 8, 2024
• Study Completion: January 8, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

AU (2); US (8)