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

Phase 1

• Conditions: Acute Leukemia; Myelodysplastic Syndrome; Solid Tumors
• Interventions: Biological: anti-thymocyte globulin; Biological: filgrastim; Radiation: Total body irradiation; Drug: Fludarabine; Drug: cyclophosphamide; Drug: Tacrolimus; Drug: Mycophenolate mofetil; Drug: Rituximab

• Registration Number: NCT01509300
• Lead Sponsor: Asan Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-01
• Study Start: 2012-01
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-12
• Last Update Submitted: 2012-01-12
• Study First Posted: 2012-01-13
• Last Update Posted: 2012-01-13
• Primary Completion: 2013-12
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HAPLO	anti-thymocyte globulin	-
HAPLO	filgrastim	-
HAPLO	Total body irradiation	-
HAPLO	Fludarabine	-
HAPLO	Rituximab	-
HAPLO	Tacrolimus	-
HAPLO	Mycophenolate mofetil	-
HAPLO	cyclophosphamide	-

Primary Outcome Measures

Name	Time	Method
Transplantation-related mortality and overall survival of TBI, Fludarabine, Cyclophosphamide and anti-thymocyte globulin for engraftment of CD3 depleted haploidentical peripheral blood stem cells.	2 years post-transplant

Secondary Outcome Measures

Name	Time	Method
Engraftment and graft failure rates	28 days engraftment and graft failure	Number of patients who failed to stable engraftment by 28 days
Incidence of acute GVHD	100 days post-transplant	Number of patients with acute GVHD.
Treatment related mortality	100 days post-transplant	Number of death after transplantation
Relapse rate and overall survival	2 year after transplantation

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of