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Randomised Study of Oral Azacitidine vs Placebo Maintenance in AML or MDS Patients After Allo-SCT

NCT04173533 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2024-05-14

No results posted yet for this study

Summary

This study will evaluate a new maintenance therapy with the aim of improving the outcome of patients with acute myeloid leukaemia (AML) and myelodysplasia (MDS) after stem cell transplantation.

Conditions

Interventions

DRUG

Oral azacitidine

Oral azacitidine (CC-486) 200 mg tablet

DRUG

Matched placebo

Oral azacitidine (CC-486) matched placebo tablet

Sponsors & Collaborators

  • University of Birmingham

    lead OTHER

Principal Investigators

  • Charles Craddock · University of Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-14
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04173533 on ClinicalTrials.gov