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

Phase 2

Active, not recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Oral Azacitidine; Other: Placebo

• Registration Number: NCT05197426
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-05
• Study Start: 2022-01-17
• Study First Posted: 2022-01-19
• Primary Completion: 2025-01-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Azacitidine	Oral Azacitidine	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Relapse-free Survival (RFS)	Up to 27 months

Secondary Outcome Measures

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

Trial Locations

Locations (31)

Local Institution - 0011; 🇺🇸 Huntsville, Alabama, United States

Local Institution - 0017; 🇯🇵 Nagoya, Aichi, Japan

Local Institution - 0023; 🇯🇵 Nagoya, Aichi, Japan

Local Institution - 0009; 🇯🇵 Toyoake, Aichi, Japan

Local Institution - 0022; 🇯🇵 Aomori-shi, Aomori, Japan

Local Institution - 0005; 🇯🇵 Kamogawa, Chiba, Japan

Local Institution - 0003; 🇯🇵 Kashiwa-shi, Chiba, Japan

Local Institution - 0010; 🇯🇵 Matsuyama, Ehime, Japan

Local Institution - 0020; 🇯🇵 Yoshida gun, Fukui, Japan

Local Institution - 0016; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Local Institution - 0014; 🇯🇵 Ogaki, Gifu, Japan

Local Institution - 0001; 🇯🇵 Maebashi, Gunma, Japan

Local Institution - 0004; 🇯🇵 Sapporo, Hokkaido, Japan

Local Institution - 0019; 🇯🇵 Kanazawa, Ishikawa, Japan

Local Institution - 0012; 🇯🇵 Isehara, Kanagawa, Japan

Local Institution - 0006; 🇯🇵 Sagamihara-shi, Kanagawa, Japan

Local Institution - 0013; 🇯🇵 Yokohama, Kanagawa, Japan

Local Institution - 0015; 🇯🇵 Sendai, Miyagi, Japan

Local Institution - 0021; 🇯🇵 Osaka Sayama, Osaka, Japan

Local Institution - 0026; 🇯🇵 Osaka shi, Osaka, Japan

Local Institution - 0031; 🇯🇵 Shimotsuke, Tochigi, Japan

Local Institution - 0032; 🇯🇵 Bunkyo Ku, Tokyo, Japan

Local Institution - 0002; 🇯🇵 Shinagawa, Tokyo, Japan

Local Institution - 0030; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Local Institution - 0029; 🇯🇵 Sumida ku, Tokyo, Japan

Local Institution - 0018; 🇯🇵 Fukuoka, Japan

Local Institution - 0027; 🇯🇵 Fukuoka, Japan

Local Institution - 0008; 🇯🇵 Nagasaki, Japan

Local Institution - 0025; 🇯🇵 Okayama, Japan

Local Institution - 0028; 🇯🇵 Saitama, Japan

Local Institution - 0007; 🇯🇵 Yamagata, Japan