At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
HLA-haploidentical Allogeneic Hematopoietic Cell Transplantation Using CD3±CD19 Depletion for Patients With Aplastic Anemia After Conditioning of Fludarabine, Cyclophosphamide and Antithymocyte Globulin
In Brief
A Phase 2 clinical trial evaluating anti-thymocyte globulin, filgrastim, and 3 other interventions for Aplastic Anemia. Completed, enrolled 12 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
On days -3 to -1
Beginning on day 4 and continuing until blood counts recover
30mg/M2 once daily IV on days -6 to -2
60 mg/kg IV on day-3 and -2
Immunogenetic depletion on CliniMACS