A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission

NCT05197426 | Active Not Recruiting Phase 2 Results FDA Drug

• 1 other identifier: CA055-005
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 31

Brief Summary

The purpose of this study is to assess the efficacy and safety of oral azacitidine plus best supportive care versus best supportive care as maintenance therapy in a cohort of Japanese participants ≥ 55 years of age with Acute Myeloid Leukemia (AML) and in complete remission/complete remission with incomplete blood count recovery after conventional induction chemotherapy with or without consolidation chemotherapy.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Recurrence Free Survival (RFS)

  The time from randomization to the date of documented relapse after CR or CRi per central review, or death from any cause, whichever occurs first. Participants who are still alive without documented relapse after CR or CRi, or who were lost to follow-up without documented relapse, will be censored at the date of their last response assessment.

  Approximately 17.7 months

Secondary Outcomes (17)

• Overall Survival (OS)

  Approximately 17.7 months

• Time to Relapse From CR or CRi

  Approximately 17.7 months

• Time to Discontinuation

  Approximately 17.7 months

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Approximately 17.7 months

• Number of Participants With Clinically Significant Changes in Physical Examination

  Approximately 17.7 months

Study Arms (2)

Oral Azacitidine

EXPERIMENTAL

Drug: Oral Azacitidine

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Oral Azacitidine DRUG

Specified dose on specified days

Also known as: CC-486, BMS-986345, Onureg

Oral Azacitidine

Placebo OTHER

Specified dose of specified days

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 55 years of age inclusive at the time of signing the informed consent
• Newly diagnosed, histologically confirmed de novo Acute Myeloid Leukemia (AML) or AML secondary to prior myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)
• Should have undergone induction therapy with intensive chemotherapy with or without consolidation therapy as recommended in appropriate guideline(s) or equivalent regimen according to institutional standard: having achieved first complete remission (CR)/complete remission with incomplete blood count recovery (CRi) status within 4 months prior to starting study therapy

You may not qualify if:

• Suspected or proven acute promyelocytic leukemia; or AML with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding MDS and CMML
• Prior bone marrow or stem cell transplantation
• Received therapy with hypomethylating agents for MDS and went on to develop AML within four months of discontinuing the therapy with hypomethylating agents
• Have achieved CR/CRi following therapy with hypomethylating agents

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (31)

Local Institution - 0011

Huntsville, Alabama, 35801, United States

Location

Local Institution - 0017

Nagoya, Aichi-ken, 453-8511, Japan

Location

Local Institution - 0023

Nagoya, Aichi-ken, 4668560, Japan

Location

Local Institution - 0009

Toyoake, Aichi-ken, 470-1192, Japan

Location

Local Institution - 0022

Aomori, Aomori, 0308553, Japan

Location

Local Institution - 0005

Kamogawa, Chiba, 2968602, Japan

Location

Local Institution - 0003

Kashiwa-shi, Chiba, 2778577, Japan

Location

Local Institution - 0010

Matsuyama, Ehime, 7900826, Japan

Location

Local Institution - 0020

Yoshida Gun, Fukui, 9101193, Japan

Location

Local Institution - 0016

Fukuoka, Fukuoka, 810-8539, Japan

Location

Local Institution - 0014

Ōgaki, Gifu, 503-8502, Japan

Location

Local Institution - 0001

Maebashi, Gunma, 3710821, Japan

Location

Local Institution - 0004

Sapporo, Hokkaido, 0640804, Japan

Location

Local Institution - 0019

Kanazawa, Ishikawa-ken, 9208641, Japan

Location

Local Institution - 0012

Isehara, Kanagawa, 2591193, Japan

Location

Local Institution - 0006

Sagamihara-shi, Kanagawa, 2520375, Japan

Location

Local Institution - 0013

Yokohama, Kanagawa, 236-0004, Japan

Location

Local Institution - 0015

Sendai, Miyagi, 9808574, Japan

Location

Local Institution - 0026

Osaka, Osaka, 5300012, Japan

Location

Local Institution - 0021

Ōsaka-sayama, Osaka, 5898511, Japan

Location

Local Institution - 0031

Shimotsuke, Tochigi, 329-0498, Japan

Location

Local Institution - 0032

Bunkyo Ku, Tokyo, 1138677, Japan

Location

Local Institution - 0002

Shinagawa, Tokyo, 141-8625, Japan

Location

Local Institution - 0030

Shinjuku-ku, Tokyo, 1600023, Japan

Location

Local Institution - 0029

Sumida Ku, Tokyo, 1308575, Japan

Location

Local Institution - 0018

Fukuoka, 810-8563, Japan

Location

Local Institution - 0027

Fukuoka, 8120033, Japan

Location

Local Institution - 0008

Nagasaki, 8528511, Japan

Location

Local Institution - 0025

Okayama, 7000914, Japan

Location

Local Institution - 0028

Saitama, 330-8503, Japan

Location

Local Institution - 0007

Yamagata, 990-9585, Japan

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine; cc-486

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

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 19, 2022
• Study Start: January 17, 2022
• Primary Completion: January 27, 2025
• Study Completion: April 30, 2026
• Last Updated: February 11, 2026
• Results First Posted: February 11, 2026

Record last verified: 2026-02

Locations

JP (30); US (1)