NCT01509300

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

HLA-haploidentical Allogeneic Hematopoietic Cell Transplantation Using CD3 Depletion for Children and Adolescents With Acute Leukemia, Myelodysplastic Syndrome and Solid Tumors After Conditioning of TBI, Fludarabine, Cyclophosphamide and Antithymocyte Globulin

• Status: Unknown
• Phase: Phase 1 / 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: 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.

Conditions

• Acute Leukemia
• Myelodysplastic Syndrome
• Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin	On days -10 to -9
BIOLOGICAL	filgrastim	Beginning on day 4 and continuing until blood counts recover
RADIATION	Total body irradiation	2Gy D-6 to D-4
DRUG	Fludarabine	30mg/M2 once daily IV on days -8 to -4
DRUG	cyclophosphamide	60 mg/kg IV on day-3 and -2
DRUG	Tacrolimus	begin on 0
DRUG	Mycophenolate mofetil	begin on 0
DRUG	Rituximab	375mg/m2 on day +21

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-12-01
• Completion: 2014-03-01
• First posted: 2012-01-13
• Last updated: 2012-01-13

Locations

1 site across 1 country: South Korea