Human Leukocyte Antigen (HLA)-Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Aplastic Anemia
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|ClinicalTrials.gov Identifier: NCT01105273|
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : January 3, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Aplastic Anemia||Biological: anti-thymocyte globulin Biological: filgrastim Drug: Fludarabine Drug: Cyclophosphamide Procedure: CD3±CD19 depleted hematopoietic stem cell transplantation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||HLA-haploidentical Allogeneic Hematopoietic Cell Transplantation Using CD3±CD19 Depletion for Patients With Aplastic Anemia After Conditioning of Fludarabine, Cyclophosphamide and Antithymocyte Globulin|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Biological: anti-thymocyte globulin
On days -3 to -1Biological: filgrastim
Beginning on day 4 and continuing until blood counts recoverDrug: Fludarabine
30mg/M2 once daily IV on days -6 to -2Drug: Cyclophosphamide
60 mg/kg IV on day-3 and -2Procedure: CD3±CD19 depleted hematopoietic stem cell transplantation
Immunogenetic depletion on CliniMACS
- To assess the engraftment rate and survival of CD3±CD19 depleted haploidentical peripheral blood stem cell transplantation after conditioning with fludarabine, cyclophosphamide and anti-thymocyte globulin. [ Time Frame: 2 years post-transplant ]
- To assess engraftment and graft failure [ Time Frame: 28 days post-transplant ]Number of patients who failed to engraft by 28 days.
- To estimate the risk of acute GVHD [ Time Frame: 100 days post-transplant ]Number of patients with acute GVHD.
- To assess treatment related mortality [ Time Frame: 100 days post-transplant ]Number of death after transplantation
- To estimate overall survival [ Time Frame: 1 year after transplantation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105273
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Principal Investigator:||Ho Joon Im, MD & PhD||Asan Medical Center|