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Autologous Hematopoietic Cell Transplantation for Core-binding Factor Acute Myeloid Leukemia

NCT01050036 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-17

No results posted yet for this study

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).

Conditions

  • Leukemia, Myeloid

Interventions

PROCEDURE

autologous hematopoietic cell transplantation

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

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Je-Hwan Lee, MD, PhD · Asan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-11
Primary Completion
2018-10-30
Completion
2018-10-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01050036 on ClinicalTrials.gov