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

October 16, 2023 updated by: Bristol-Myers Squibb

A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Subjects With Acute Myeloid Leukemia in Complete Remission

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • Japan
      • Aomori, Japan, 030-8553
        • Recruiting
        • Local Institution - 0022
        • Contact:
          • Site 0022
      • Fukuoka, Japan, 810-8563
        • Recruiting
        • Local Institution - 0018
        • Contact:
          • Site 0018
      • Fukuoka, Japan, 8120033
        • Recruiting
        • Local Institution - 0027
        • Contact:
          • Site 0027
      • Nagasaki, Japan, 8528511
        • Recruiting
        • Local Institution - 0008
        • Contact:
          • Site 0008
      • Nagoya-shi, Japan, 466-8560
        • Recruiting
        • Local Institution - 0023
        • Contact:
          • Site 0023
      • Okayama, Japan, 700-8558
        • Recruiting
        • Local Institution - 0025
        • Contact:
          • Site 0025
      • Osaka, Japan, 5300012
        • Recruiting
        • Local Institution - 0026
        • Contact:
          • Site 0026
      • Yamagata, Japan, 990-9585
        • Recruiting
        • Local Institution - 0007
        • Contact:
          • Site 0007
    • Aichi
      • Nagoya, Aichi, Japan, 4538511
        • Recruiting
        • Local Institution - 0017
        • Contact:
          • Site 0017
      • Toyoake, Aichi, Japan, 470-1192
        • Recruiting
        • Local Institution - 0009
        • Contact:
          • Site 0009
    • Chiba
      • Kamogawa, Chiba, Japan, 2968602
        • Recruiting
        • Local Institution - 0005
        • Contact:
          • Site 0005
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Recruiting
        • Local Institution - 0003
        • Contact:
          • Site 0003
    • Ehime
      • Matsuyama, Ehime, Japan, 7900826
        • Recruiting
        • Local Institution - 0010
        • Contact:
          • Site 0010
    • Fukui
      • Yoshida gun, Fukui, Japan, 9101193
        • Recruiting
        • Local Institution - 0020
        • Contact:
          • Site 0020
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 810-8539
        • Recruiting
        • Local Institution - 0016
        • Contact:
          • Site 0016
    • Gifu
      • Ogaki, Gifu, Japan, 503-8502
        • Recruiting
        • Local Institution - 0014
        • Contact:
          • Site 0014
    • Gunma
      • Maebashi, Gunma, Japan, 3710821
        • Recruiting
        • Local Institution - 0001
        • Contact:
          • Site 0001
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 064-0804
        • Recruiting
        • Local Institution - 0004
        • Contact:
          • Site 0004
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 9208641
        • Recruiting
        • Local Institution - 0019
        • Contact:
          • Site 0019
    • Kanagawa
      • Isehara, Kanagawa, Japan, 2591193
        • Recruiting
        • Local Institution - 0012
        • Contact:
          • Site 0012
      • Sagamihara, Kanagawa, Japan, 2520375
        • Recruiting
        • Local Institution - 0006
        • Contact:
          • Site 0006
      • Yokohama, Kanagawa, Japan, 2360004
        • Recruiting
        • Local Institution - 0013
        • Contact:
          • Site 0013
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 9808574
        • Recruiting
        • Local Institution - 0015
        • Contact:
          • Site 0015
    • Osaka
      • Osaka Sayama, Osaka, Japan, 5898511
        • Recruiting
        • Local Institution - 0021
        • Contact:
          • Site 0021
    • Saitama
      • Saitama shi, Saitama, Japan, 3308503
        • Recruiting
        • Local Institution - 0028
        • Contact:
          • Site 0028
    • Tochigi
      • Shimotsuke, Tochigi, Japan, 3290498
        • Recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
    • Tokyo
      • Bunkyo Ku, Tokyo, Japan, 1138677
        • Recruiting
        • Local Institution - 0032
        • Contact:
          • Site 0032
      • Shinagawa ku, Tokyo, Japan, 1418625
        • Recruiting
        • Local Institution - 0002
        • Contact:
          • Site 0002
      • Shinjyuku Ku, Tokyo, Japan, 1600023
        • Recruiting
        • Local Institution - 0030
        • Contact:
          • Site 0030
      • Sumida ku, Tokyo, Japan, 1308575
        • Recruiting
        • Local Institution - 0029
        • Contact:
          • Site 0029
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • Local Institution - 0011
        • Contact:
          • Site 0011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥ 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

Exclusion Criteria:

  • 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

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Specified dose of specified days
Experimental: Oral Azacitidine
Drug: Oral Azacitidine
Specified dose on specified days
Other Names:
  • Onureg
  • CC-486
  • BMS-986345

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relapse-free Survival (RFS)
Time Frame: Up to 27 months
Up to 27 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 27 months
Up to 27 months
Time to relapse from Complete Remission (CR)
Time Frame: Up to 27 months
Up to 27 months
Time to relapse from complete remission with incomplete blood count recovery (CRi)
Time Frame: Up to 27 months
Up to 27 months
Time to discontinuation from treatment
Time Frame: Up to 27 months
Up to 27 months
Number of participants with Adverse Events
Time Frame: Up to 50 months
Up to 50 months
Number of participants with physical examination abnormalities
Time Frame: Up to 50 months
Up to 50 months
Number of participants with vital sign abnormalities
Time Frame: Up to 50 months
Up to 50 months
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 50 months
Up to 50 months
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 27 months
Up to 27 months
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to 27 months
Up to 27 months
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Time Frame: Up to 27 months
Up to 27 months
Area under the serum concentration-time curve from time 0 to infinity AUC(INF)
Time Frame: Up to 27 months
Up to 27 months
Number of participant-reported outcomes utilizing the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale
Time Frame: Up to 27 months
Up to 27 months
Number of participant-reported outcomes utilizing the EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L)
Time Frame: Up to 27 months
Up to 27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2022

Primary Completion (Estimated)

January 27, 2025

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA055-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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