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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 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.

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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.

Conditions Studied

Acute Myeloid Leukemia

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

FieldValue
Enrollment Target 19 participants
Start Date 2022-01-17
Est. Completion 2026-04-30
Phase Phase 2

Sponsor

Bristol-Myers Squibb

1,025 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05197426

The ClinicalTrials.gov registry entry for NCT05197426 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (84% lower). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.