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ACTIVE NOT RECRUITING 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

NCT05197426 · View on ClinicalTrials.gov ↗

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

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

504 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05197426 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Aichi-ken, Kanagawa, Chiba. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05197426?

The interventions under investigation include: Placebo (OTHER), Oral Azacitidine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05197426?

This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial