The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)

Official Title

A Phase 3, Multicentre, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia Due to IPSS Lower-risk Myelodysplastic Syndromes.

Summary:

Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk myelodysplastic syndromes (MDS).

Trial Description

Primary Outcome:

  • Red blood cell (RBC) transfusion independence
Secondary Outcome:
  • Number of patients alive
  • Hematological improvement-platelet response (HI-P)
  • Duration of RBC transfusion independence
  • Time to RBC transfusion independence
  • Progression to acute myeloid leukemia (AML)
  • Time to AML progression
  • Hematological improvement-erythroid response (HI-E)
  • Platelet-transfusion independence
  • Duration of platelet transfusion independence
  • Time to platelet transfusion independence
  • Hematologic response
  • Clinically significant bleeding events
  • Number of subjects with adverse events
  • Health-related quality-of-life
  • Healthcare resource utilization

View this trial on ClinicalTrials.gov

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Resources

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