Acute Myeloid Leukemia Clinical Trial
Official title:
Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)
This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for
treatment of newly diagnosed AML patients, younger than 66 years.
Trial is based on:
- INDUCTION: FLAI + Gemtuzumab-Ozogamicin (FLAI-GO).
- CONSOLIDATION: Intermediate dose AraC + IDA (IDAC+IDA) +/- one course of high dose AraC
(HDAC)
- INTENSIFICATION: Allo-BMT, ASCT
- MAINTENANCE: AraC
a) Primary endpoints:
- Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.
- RFS, DFS and OS.
b) Secondary endpoints:
- Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression
and monitoring.
- Evaluation of prognostic clinical relevance of biological features at onset.
- Feasibility and outcome of consolidation with BMT.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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