Treatment Study for Patients with Acute Myeloid Leukemia with FLT3 Mutation
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.
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.