Multicenter prospective observational study of hematopoietic stem cell transplantation after quizartinib in patients with FLT3-ITD positive relapsed or refractory acute myeloid leukemia .
- Conditions
- Acute myeloid leukemia
- Registration Number
- JPRN-UMIN000043659
- Lead Sponsor
- Kanto Study Group for Cell Therapy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Not provided
1) Patients treated with quizartinib 2) Patients with multiple malignancies other than AML 3) Patients diagnosed with acute promyelocytic leukemia 4) Patients with a QTcF (Fridericia-corrected QT interval) greater than 450 msec as a result of the latest electrocardiogram measured within 14 days prior to enrollment 5) Patients known to have HIV or HBV 6) Patients who have already achieved remission with treatment other than quizartinib at the stage of disease ("primary" or "relapsed or refractory") at the time of enrollment and are scheduled to receive allo-HSCT. 7) Pregnant or lactating patients, or patients who may be breastfeeding within 5 weeks of the last dose of quizartinib 8) Patients who are otherwise classified as unfit by the attending physicians for this research.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical data of hematopoietic stem cell transplantation after quizartinib Reasons for allogeneic transplant Stem cell source Event-free survival: EFS Conditioning regimen Graft-versus-host disease :GVHD Cumulative incidences of relapse:CIR Cumulative incidences of non relapse mortality:NRM Clinical data for outcomes of quizartinib bridge to transplantation rate CRc[Composite complete remission]; CR[Complete remission]+CRi[Complete remission with incomplete hematologic recovery] Overall response rate: ORR Time to CRc Overall survival: OS Blood transfusion dependency rate Re-administration of quizartinib Adverse events of quizartinib
- Secondary Outcome Measures
Name Time Method