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NCT05469737 · ClinicalTrials.gov registry record · Phase 2

A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)

A Phase 2 study of Myelodysplastic Syndromes, sponsored by Bristol-Myers Squibb.

Active
Registry status
Phase 2
Development phase
230
Enrollment target
20
Study locations

NCT05469737 is a Phase 2 study of Myelodysplastic Syndromes that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 230 participants, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT05469737, a Phase 2 study of Myelodysplastic Syndromes, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
230 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS).

Conditions Studied

Myelodysplastic Syndromes

Interventions

  • DRUG Oral Azacitidine
  • DRUG Placebo for Oral Azacitidine

Study Locations (20)

Other

  • Local Institution - 0016 - Buenos Aires
  • Local Institution - 0022 - Buenos Aires
  • Local Institution - 0050 - Buenos Aires
  • Local Institution - 0003 - Melbourne

Victoria

  • Local Institution - 0006 - Clayton
  • Local Institution - 0018 - Melbourne
  • Local Institution - 0004 - Melbourne

Florida

  • Local Institution - 0137 - Miami
  • Local Institution - 0147 - Tamarac

Texas

  • Local Institution - 0014 - Houston
  • Local Institution - 0086 - Houston

Ontario

  • Local Institution - 0008 - Toronto
  • Local Institution - 0015 - Toronto

New York

  • Local Institution - 0132 - East Syracuse

Pennsylvania

  • Local Institution - 0073 - Pittsburgh

Virginia

  • Local Institution - 0123 - Fairfax

Trial Details

FieldValue
Enrollment Target 230 participants
Start Date 2022-12-14
Est. Completion 2028-07-31
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 NCT05469737

The ClinicalTrials.gov registry entry for NCT05469737 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (19% 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 Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions - of which Oral Azacitidine is the first listed.

NCT05469737 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Victoria, Florida.

Frequently Asked Questions

What is clinical trial NCT05469737 about?

NCT05469737 is a clinical study titled "A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)". The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS).

What is the current status of trial NCT05469737?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 230 participants. The study started on 2022-12-14. Estimated completion is 2028-07-31.

What conditions does trial NCT05469737 study?

This clinical trial studies the following conditions: Myelodysplastic Syndromes.

What interventions are being tested in trial NCT05469737?

The interventions under investigation include: Oral Azacitidine (DRUG), Placebo for Oral Azacitidine (DRUG).

Who is sponsoring clinical trial NCT05469737?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05469737 being conducted?

This trial has 20 study locations across Florida, New York, Pennsylvania, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.