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HLA-haploidentical Hematopoietic Stem Cell Transplantation for Children and Adolescents With Acute Leukemia, Myelodysplastic Syndrome and Solid Tumors

NCT01509300 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-01-13

No results posted yet for this study

Summary

RATIONALE: Conditioning with total body irradiation (TBI) and fludarabine, cyclophosphamide and anti-thymocyte globulin may induce the engraftment cross the immunologic barrier in the setting of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition, T-cell depletion may contribute to prevent developing severe acute graft versus host disease (GVHD) in haploidentical transplantation.

PURPOSE: This phase I/II trial is to evaluate the safety and efficacy of TBI, fludarabine, cyclophosphamide and antithymocyte globulin with T-cell depleted graft from haploidentical donors in treating patients with acute leukemia and myelodysplastic syndrome.

Conditions

Interventions

BIOLOGICAL

anti-thymocyte globulin

On days -10 to -9

BIOLOGICAL

filgrastim

Beginning on day 4 and continuing until blood counts recover

RADIATION

Total body irradiation

2Gy D-6 to D-4

DRUG

Fludarabine

30mg/M2 once daily IV on days -8 to -4

DRUG

cyclophosphamide

60 mg/kg IV on day-3 and -2

DRUG

Tacrolimus

begin on 0

DRUG

Mycophenolate mofetil

begin on 0

DRUG

Rituximab

375mg/m2 on day +21

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Ho Joon Im, MD & PhD · Asan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-12-31
Completion
2014-03-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

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 NCT01509300 on ClinicalTrials.gov