MedTrace Logo

Donor-specific Allogeneic Hematopoietic Cell Transplantation for Acute Lymphoblastic Leukemia (ALL)

NCT01037764 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-07-20

No results posted yet for this study

Summary

\[Study Objectives\]

* To evaluate the efficacy of allogeneic hematopoietic cell transplantation (HCT) in patients with acute lymphoblastic leukemia (ALL) in the first or second complete remission (CR). The efficacy of the treatment will be measured in terms of the frequency of relapse and duration of remission (the primary endpoints).
* The secondary end points of the study include; engraftment, donor chimerism, secondary graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery, infections, transplantation-related mortality, leukemia free survival, and overall survival.

Conditions

  • Acute Lymphoid Leukemia

Interventions

PROCEDURE

alloHCT

\[ alloHCT arm \] Bu-Cy conditioning; Busulfan (Bu) 3.2 mg/kg\*/day iv daily on days -7 and -4. Cyclophosphamide (Cy) 60 mg/kg\* in D5W 200 mL iv over 1-2 hours daily on days -3 and -2. BuFluATG conditioning; Bu 3.2 mg/kg\*/day iv daily on days -7 and -6. Fludarabine (Flu) 30 mg/m2/day in D5W 100 ml iv over 30 minutes starting at 4 pm daily on days -7, -6, -5, -4, -3, and -2. Anti-thymocyte globulin (ATG, Thymoglobulin, Genzyme Transplant, Cambridge, MA, USA) 1.5 mg/kg/day (for HLA-matched sibling HCT) or 3.0 mg/kg/day (for HLA-matched unrelated donor HCT or HLA-mismatched familial donor HCT) in N/S 500-800 ml (less than 4 mg/ml) iv over 4 hours starting at 8 am daily on days , -3, -2 and -1.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Dae-Young Kim, M.D. & PhD · Asan Medical Center

  • Kyoo-Hyung Lee, M.D. & PhD. · Asan Medical Center

  • Je-Hwan Lee, M.D. & PhD. · Asan Medical Center

  • Jung-Hee Lee, M.D. & PhD. · Asan Medical Center

  • Young-Don Joo, MD, PhD · Inje University Haeundae Paik Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-12-31
Completion
2016-12-31

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT01037764 on ClinicalTrials.gov