NCT01759732

Haploidentical Stem Cell Transplantation for Children With Acquired Severe Aplastic Anemia

Haploidentical Stem Cell Transplantation With Fixed Dose of T Cells After in Vitro T Cell Depletion Using CD3 Monoclonal Antibody for Children With Acquired Severe Aplastic Anemia

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Rationale: Fludarabine, cyclophosphamide, anti-thymocyte globulin and low-dose total body irradiation (LD-TBI) may induce the engraftment cross the immunologic barrier in the setting of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition, depletion of CD3 cells may contribute to prevent developing severe acute graft versus host disease (GVHD) in haploidentical transplantation. Purpose: Phase II trials to evaluate the efficacy of haploidentical stem cell transplantation with fixed dose of T cells after in vitro T cell depletion using CD3 monoclonal antibody for children with acquired severe aplastic anemia

Conditions

• Acquired Aplastic Anemia

Interventions

Type	Name	Description
DRUG	Fludarabine	40mg/M2 once daily IV on days -7 to -4
DRUG	Cyclophosphamide	60 mg/kg IV on day-3 and -2
BIOLOGICAL	anti-thymocyte globulin
BIOLOGICAL	filgrastim
RADIATION	Total body irradiation	200 cGy per day on D-5 \& -4
PROCEDURE	CD3-depleted hematopoietic cell transplantation	Immunogenetic depletion on CliniMACS

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2013-01-03
• Last updated: 2013-01-03

Locations

1 site across 1 country: South Korea