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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05197426
• Other study ID #: CA055-005
• Status: Recruiting
• Phase: Phase 2
• Start date: January 17, 2022
• Est. completion date: April 30, 2026

Study information

• Verified date: October 2023
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: April 30, 2026
• Est. primary completion date: January 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Oral Azacitidine
Specified dose on specified days

Other:
• Placebo
Specified dose of specified days

Locations

Country	Name	City	State
Japan	Local Institution - 0022	Aomori
Japan	Local Institution - 0032	Bunkyo Ku	Tokyo
Japan	Local Institution - 0018	Fukuoka
Japan	Local Institution - 0027	Fukuoka
Japan	Local Institution - 0016	Fukuoka-shi	Fukuoka
Japan	Local Institution - 0012	Isehara	Kanagawa
Japan	Local Institution - 0005	Kamogawa	Chiba
Japan	Local Institution - 0019	Kanazawa	Ishikawa
Japan	Local Institution - 0003	Kashiwa-shi	Chiba
Japan	Local Institution - 0001	Maebashi	Gunma
Japan	Local Institution - 0010	Matsuyama	Ehime
Japan	Local Institution - 0008	Nagasaki
Japan	Local Institution - 0017	Nagoya	Aichi
Japan	Local Institution - 0023	Nagoya-shi
Japan	Local Institution - 0014	Ogaki	Gifu
Japan	Local Institution - 0025	Okayama
Japan	Local Institution - 0026	Osaka
Japan	Local Institution - 0021	Osaka Sayama	Osaka
Japan	Local Institution - 0006	Sagamihara	Kanagawa
Japan	Local Institution - 0028	Saitama shi	Saitama
Japan	Local Institution - 0004	Sapporo	Hokkaido
Japan	Local Institution - 0015	Sendai-shi	Miyagi
Japan	Local Institution - 0031	Shimotsuke	Tochigi
Japan	Local Institution - 0002	Shinagawa ku	Tokyo
Japan	Local Institution - 0030	Shinjyuku Ku	Tokyo
Japan	Local Institution - 0029	Sumida ku	Tokyo
Japan	Local Institution - 0009	Toyoake	Aichi
Japan	Local Institution - 0007	Yamagata
Japan	Local Institution - 0013	Yokohama	Kanagawa
Japan	Local Institution - 0020	Yoshida gun	Fukui
United States	Local Institution - 0011	Huntsville	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls