NCT04173533

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

A Double-Blind, Phase III, Randomised Study to Compare the Efficacy and Safety of Oral Azacitidine (CC-486) Versus Placebo in Subjects With Acute Myeloid Leukaemia or Myelodysplastic Syndromes as Maintenance After Allogeneic Haematopoietic Stem Cell Transplantation

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, two arm, double-blind, phase III clinical trial in adult patients with acute myeloid leukaemia (AML) and myelodysplasia (MDS) who have undergone an allogeneic stem cell transplant (allo-SCT) and are randomised to receive oral azacitidine or placebo upon engraftment for up to 12 months as maintenance therapy. Patients will be stratified by type of transplant (myeloablative/reduced intensity, age (\<60/≥ 60 years) and donor type (sibling/unrelated)).

Conditions

• Acute Myeloid Leukemia
• Myelodysplasia

Interventions

Type	Name	Description
DRUG	Oral azacitidine	Oral azacitidine (CC-486) 200 mg tablet
DRUG	Matched placebo	Oral azacitidine (CC-486) matched placebo tablet

Timeline

• Start date: 2019-06-14
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2019-11-22
• Last updated: 2024-05-14

Locations

20 sites across 1 country: United Kingdom