Selinexor (KPT-330) in Older Patients With Relapsed AML

Official Title

A Randomized, Open Label, Phase 2 Study of the Selective Inhibitor of Nuclear Export (Sine) Selinexor (KPT-330) Versus Specified Physician's Choice in Patients ≥ 60 Years Old With Relapsed/Refractory Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy and/or Transplantation

Summary:

This is a randomized, multicentre, open-label, Phase 2 study of the SINE Selinexor given orally versus specified investigator choices (one of three potential salvage therapies). Patients age ≥ 60 years with relapsed/refractory AML of any type except for AML M3, after one prior therapy only, who have never undergone and who are not currently eligible for stem cell transplantation and are currently deemed unfit for intensive chemotherapy.

Trial Description

Primary Outcome:

  • Overall survival
Secondary Outcome:
  • 3 month survival
This is a randomized, multicentre, open-label phase 2 study of the SINE Selinexor given orally versus restricted investigator choice (i.e., one of three potential salvage therapies). Patients who have never been transplant eligible, are currently deemed unfit for intensive chemotherapy, ≥ 60 years old, who have AML (except Acute Promyelocytic Leukemia: APL, AML M3) after one prior treatment of either hypomethylating agent or a regimen including Ara-C, and are meeting the inclusion and exclusion criteria will be randomized to receive either oral Selinexor or physician's choice (one of three potential treatments: best supportive care (BSC) alone, or BSC + hypomethylating agent, or BSC + low dose Ara-C until disease progression, death or intolerance has occurred.

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