Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML

Official Title

A Phase II, Randomized Trial of Standard of Care, With or Without Midostaruin to Prevent Relapse Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With FLT3-ITD Mutated Acute Myeloid Leukemia

Summary:

To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,

Trial Description

Primary Outcome:

  • Relapse Free Survival (RFS)
Secondary Outcome:
  • Disease Free Survival (DFS)
  • Non-Relapse Mortality (NRM)
  • Overall Survival (OS)
  • FLT3-ITD mutation status centrally in archived material from diagnosis (if available) including mutant:wild type ratio
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability
  • Plasma Pharmacokinetics (PK) of midostaurin and the metabolites: CGP62221 and CGP52421: Pre-dose levels
  • Plasma Pharmacokinetics (PK) of midostaurin and the metabolites: CGP62221 and CGP52421: Pre-dose levels

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society