NCT01105273

Human Leukocyte Antigen (HLA)-Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Aplastic Anemia

HLA-haploidentical Allogeneic Hematopoietic Cell Transplantation Using CD3±CD19 Depletion for Patients With Aplastic Anemia After Conditioning of Fludarabine, Cyclophosphamide and Antithymocyte Globulin

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Rationale: Chemotherapy with 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, depletion CD3±CD19 cells 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 fludarabine, cyclophosphamide and antithymocyte globulin with CD3±CD19 depleted graft from haploidentical donors in treating patients with aplastic anemia.

Conditions

• Aplastic Anemia

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin	On days -3 to -1
BIOLOGICAL	filgrastim	Beginning on day 4 and continuing until blood counts recover
DRUG	Fludarabine	30mg/M2 once daily IV on days -6 to -2
DRUG	Cyclophosphamide	60 mg/kg IV on day-3 and -2
PROCEDURE	CD3±CD19 depleted hematopoietic stem cell transplantation	Immunogenetic depletion on CliniMACS

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-04-16
• Last updated: 2013-01-03

Locations

1 site across 1 country: South Korea