Cyclophosphamide, Antithymocyte Globulin, and Total-Body Irradiation in Treating Patients With Severe Aplastic Anemia Undergoing Umbilical Cord Blood Transplant
RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.
PURPOSE: This phase I trial is studying the side effects and best dose of total-body irradiation when given together with cyclophosphamide and antithymocyte globulin in treating patients with severe aplastic anemia undergoing umbilical cord blood transplant.
Radiation: total-body irradiation
Biological: anti-thymocyte globulin
Procedure: umbilical cord blood transplantation
Drug: mycophenolate mofetil
Procedure: bone marrow aspiration
Genetic: DNA analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Dose Finding Study of Total Body Irradiation for Conditioning Patients With Severe Aplastic Anemia Transplanted With Umbilical Cord Blood|
- Toxicity [ Designated as safety issue: Yes ]
- Engraftment [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm I
See Detailed Description
Radiation: total-body irradiation
Other Name: TBIDrug: cyclophosphamide
Other Names:Biological: anti-thymocyte globulin
Other Names:Drug: cyclosporine
Other Names:Procedure: umbilical cord blood transplantation
Other Names:Drug: mycophenolate mofetil
Given IV or orally
Other Names:Procedure: bone marrow aspiration
Correlative studyGenetic: DNA analysis
Correlative studyBiological: filgrastim
Given IV or SC
I. The objective of this study is to determine the lowest dose of total body irradiation combined with cyclophosphamide and antithymocyte globulin that will achieve sustained engraftment in patients with severe aplastic anemia transplanted with unrelated umbilical cord blood.
OUTLINE: This is a dose-escalation study of total-body irradiation (TBI).
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 to -4, -6 to -3, or -5 to -2 and antithymocyte globulin IV on days -6 to -4, -5 to -3, or -4 to -2.
TBI: Patients undergo TBI twice daily on days -3, -2, and/or -1.
UMBILICAL CORD BLOOD TRANSPLANTATION (UCBT): Patients undergo UCBT on day 0. Patients receive filgrastim (G-CSF) IV or subcutaneously beginning on day 1 and continuing until blood counts recover.
GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive cyclosporine IV or orally (twice daily for patients >= 6 years of age or 3 times daily for patients < 6 years of age) on days -1 to +180 and mycophenolate mofetil IV or orally (twice daily for patients >= 50 kg or 3 times daily for patients < 50 kg) beginning 4 hours after UCBT and continuing until approximately day +0.
After completion of study therapy, patients are followed periodically.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354419
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Ann Woolfrey||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|