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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

Primary Purpose

Acute Myeloid Leukemia

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Oral Azacitidine
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution - 0011Recruiting
  • Local Institution - 0017Recruiting
  • Local Institution - 0009Recruiting
  • Local Institution - 0005Recruiting
  • Local Institution - 0003Recruiting
  • Local Institution - 0010Recruiting
  • Local Institution - 0020Recruiting
  • Local Institution - 0016Recruiting
  • Local Institution - 0014Recruiting
  • Local Institution - 0001Recruiting
  • Local Institution - 0004Recruiting
  • Local Institution - 0019Recruiting
  • Local Institution - 0012Recruiting
  • Local Institution - 0006Recruiting
  • Local Institution - 0013Recruiting
  • Local Institution - 0015Recruiting
  • Local Institution - 0021Recruiting
  • Local Institution - 0028Recruiting
  • Local Institution - 0031Recruiting
  • Local Institution - 0032Recruiting
  • Local Institution - 0002Recruiting
  • Local Institution - 0030Recruiting
  • Local Institution - 0029Recruiting
  • Local Institution - 0022Recruiting
  • Local Institution - 0018Recruiting
  • Local Institution - 0027Recruiting
  • Local Institution - 0008Recruiting
  • Local Institution - 0023Recruiting
  • Local Institution - 0025Recruiting
  • Local Institution - 0026Recruiting
  • Local Institution - 0007Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oral Azacitidine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Relapse-free Survival (RFS)

Secondary Outcome Measures

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

Full Information

First Posted
January 5, 2022
Last Updated
October 16, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05197426
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2022 (Actual)
Primary Completion Date
January 27, 2025 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral Azacitidine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oral Azacitidine
Other Intervention Name(s)
CC-486, BMS-986345, Onureg
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose of specified days
Primary Outcome Measure Information:
Title
Relapse-free Survival (RFS)
Time Frame
Up to 27 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
Up to 27 months
Title
Time to relapse from Complete Remission (CR)
Time Frame
Up to 27 months
Title
Time to relapse from complete remission with incomplete blood count recovery (CRi)
Time Frame
Up to 27 months
Title
Time to discontinuation from treatment
Time Frame
Up to 27 months
Title
Number of participants with Adverse Events
Time Frame
Up to 50 months
Title
Number of participants with physical examination abnormalities
Time Frame
Up to 50 months
Title
Number of participants with vital sign abnormalities
Time Frame
Up to 50 months
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Up to 50 months
Title
Maximum observed plasma concentration (Cmax)
Time Frame
Up to 27 months
Title
Time of maximum observed plasma concentration (Tmax)
Time Frame
Up to 27 months
Title
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
Title
Area under the serum concentration-time curve from time 0 to infinity AUC(INF)
Time Frame
Up to 27 months
Title
Number of participant-reported outcomes utilizing the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale
Time Frame
Up to 27 months
Title
Number of participant-reported outcomes utilizing the EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L)
Time Frame
Up to 27 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain NCT # and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0011
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0011
Facility Name
Local Institution - 0017
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4538511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017
Facility Name
Local Institution - 0009
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0009
Facility Name
Local Institution - 0005
City
Kamogawa
State/Province
Chiba
ZIP/Postal Code
2968602
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0005
Facility Name
Local Institution - 0003
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0003
Facility Name
Local Institution - 0010
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
7900826
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0010
Facility Name
Local Institution - 0020
City
Yoshida gun
State/Province
Fukui
ZIP/Postal Code
9101193
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0020
Facility Name
Local Institution - 0016
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-8539
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0016
Facility Name
Local Institution - 0014
City
Ogaki
State/Province
Gifu
ZIP/Postal Code
503-8502
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0014
Facility Name
Local Institution - 0001
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
3710821
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0001
Facility Name
Local Institution - 0004
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
064-0804
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0004
Facility Name
Local Institution - 0019
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
9208641
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0019
Facility Name
Local Institution - 0012
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
2591193
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0012
Facility Name
Local Institution - 0006
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
2520375
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0006
Facility Name
Local Institution - 0013
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
2360004
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0013
Facility Name
Local Institution - 0015
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0015
Facility Name
Local Institution - 0021
City
Osaka Sayama
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0021
Facility Name
Local Institution - 0028
City
Saitama shi
State/Province
Saitama
ZIP/Postal Code
3308503
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0028
Facility Name
Local Institution - 0031
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
3290498
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0031
Facility Name
Local Institution - 0032
City
Bunkyo Ku
State/Province
Tokyo
ZIP/Postal Code
1138677
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0032
Facility Name
Local Institution - 0002
City
Shinagawa ku
State/Province
Tokyo
ZIP/Postal Code
1418625
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0002
Facility Name
Local Institution - 0030
City
Shinjyuku Ku
State/Province
Tokyo
ZIP/Postal Code
1600023
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0030
Facility Name
Local Institution - 0029
City
Sumida ku
State/Province
Tokyo
ZIP/Postal Code
1308575
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0029
Facility Name
Local Institution - 0022
City
Aomori
ZIP/Postal Code
030-8553
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0022
Facility Name
Local Institution - 0018
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0018
Facility Name
Local Institution - 0027
City
Fukuoka
ZIP/Postal Code
8120033
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0027
Facility Name
Local Institution - 0008
City
Nagasaki
ZIP/Postal Code
8528511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0008
Facility Name
Local Institution - 0023
City
Nagoya-shi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0023
Facility Name
Local Institution - 0025
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0025
Facility Name
Local Institution - 0026
City
Osaka
ZIP/Postal Code
5300012
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0026
Facility Name
Local Institution - 0007
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0007

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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