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NCT05197426 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Acute Myeloid Leukemia, sponsored by Bristol-Myers Squibb.
- Active
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 20
- Study locations
NCT05197426: Active Phase 2 study of Acute Myeloid Leukemia, sponsored by Bristol-Myers Squibb.
NCT05197426 is a Phase 2 study of Acute Myeloid Leukemia that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 19 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05197426, a Phase 2 study of Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Oral Azacitidine
Study Locations (20)
Aichi-ken
- Local Institution - 0017 - Nagoya
- Local Institution - 0023 - Nagoya
- Local Institution - 0009 - Toyoake
Kanagawa
- Local Institution - 0012 - Isehara
- Local Institution - 0006 - Sagamihara-shi
- Local Institution - 0013 - Yokohama
Chiba
- Local Institution - 0005 - Kamogawa
- Local Institution - 0003 - Kashiwa-shi
Osaka
- Local Institution - 0026 - Osaka
- Local Institution - 0021 - Ōsaka-sayama
Alabama
- Local Institution - 0011 - Huntsville
Aomori
- Local Institution - 0022 - Aomori
Ehime
- Local Institution - 0010 - Matsuyama
Fukui
- Local Institution - 0020 - Yoshida Gun
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2022-01-17 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 2 |
What the registry record for NCT05197426 still lists
NCT05197426 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05197426 names 20 study sites across 14 states, led by Aichi-ken, Kanagawa, Chiba.
Frequently Asked Questions
What is clinical trial NCT05197426 about?
NCT05197426 is a clinical study titled "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". 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 i...
What is the current status of trial NCT05197426?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2022-01-17. Estimated completion is 2026-04-30.
What conditions does trial NCT05197426 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT05197426?
The interventions under investigation include: Placebo (OTHER), Oral Azacitidine (DRUG).
Who is sponsoring clinical trial NCT05197426?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05197426 being conducted?
This trial has 20 study locations across Alabama, Aichi-ken, Aomori, Chiba, Ehime. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05197426's enrollment target sits among peer trials
19 258th of 306 higher than 49 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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