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Treatment Study for Patients with Acute Myeloid Leukemia with FLT3 Mutation

Clinical Trial Title: 
A phase 3 open-label, multicenter, randomized study of ASP2215 versus salvage chemotherapy in patients with relapsed or refractory acute myeloid leukemia (AML) with FLT3 mutation.
Clinical Trial Protocol ID: 
16071503
Clinical Trial Investigator Name: 
Melissa L. Larson, MD
Clinical Trial Protocol Description: 

Study for newly diagnosed AML patients with a FLT3 mutation, which compares salvage therapy to treatment with study drug and to collect additional data on treatment safety.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are refractory to or relapsed after first-line AML therapy (with or without HSCT).
    • Refractory to first-line AML therapy is defined as: Subject did not achieve CR/CRi/CRp under initial therapy. A subject eligible for standard therapy must receive at least 1 cycle of an anthracycline containing induction block in standard dose for the selected induction regimen. A subject not eligible for standard therapy must have received at least 1 complete block of induction therapy seen as the optimum choice of therapy to induce remission for this subject as per investigator’s assessment.
    • Untreated first hematologic relapse is defined as: Subject must have achieved a CR/CRi/CRp with first-line treatment and has hematologic relapse.
  • Are positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab. In the investigator’s opinion, a subject with rapidly proliferative disease and unable to wait for the central lab results can be enrolled based on a local test performed after completion of the last interventional treatment. Subjects can be enrolled from a local test result if they have any of the following FLT3 mutations: FLT3-ITD, FLT3-TKD/D835 or FLT3-TKD/I836.
  • Have an ECOG performance status ≤ 2.

You will be excluded from the study if any of the following criteria apply to you:

  • Have been diagnosed as acute promyelocytic leukemia.
  • Have BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
  • Have AML secondary to prior chemotherapy for other neoplasms (except for MDS).
  • Are in second or later hematologic relapse or has received salvage therapy for refractory disease.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Blood Disorders and Hematologic Cancers
Contact Phone: 
(312) 942-1346
Contact Name: 
Kimberly Koetter, BS, RN, OCN, CCRC