At a glance
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Phase 2 Study of Autologous Hematopoietic Cell Transplantation for Core-binding Factor Positive Acute Myeloid Leukemia in the First Complete Remission
In Brief
A clinical study evaluating autologous hematopoietic cell transplantation for Leukemia, Myeloid. Completed, enrolled 20 participants across 11 sites.
Detailed Summary
Primary study objective is the evaluation of efficacy of autologous hematopoietic cell transplantation (HCT) with core-binding factor (CBF) positive acute myeloid leukemia (AML) in the first CR (CR1) in terms of relapse incidence (cumulative incidence of relapse, CIR) and disease-free survival (DFS). Secondary study objectives are the engraftment rate / time to engraftment, transplantation-related mortality (TRM) rate, event-free survival (EFS) rate, and Overall survival (OS).
Study Details
Timeline
Interventions
1. Autologous peripheral blood stem cell (PBSCs) harvesting * After the second cycle of high-dose ara-C(HDAC) consolidation chemotherapy * Mobilization: recombinant human G-CSF(Filgrastim) 5mcg/kg s.c. daily starting on 10 days after start of the second cycle of HDAC chemotherapy * Harvest procedure: peripheral blood mononuclear cells will be collected. Target CD34+ cell dose is over 5x10E6/kg. 2. Conditioning regimen for autologous HCT * Busulfan 3.2 mg/kg/day i.v. daily on days -7 to -5 (for 3 days) * Etoposide 400mg/m2/day i.v. daily on days -3 to -2 (for 2 days) 3. Autologous cell infusion and waiting for engraftment