Status:
TERMINATED
Cyclophosphamide, Antithymocyte Globulin, and Total-Body Irradiation in Treating Patients With Severe Aplastic Anemia Undergoing Umbilical Cord Blood Transplant
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Aplastic Anemia
Eligibility:
All Genders
Up to 40 years
Phase:
PHASE1
Brief Summary
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 syst...
Detailed Description
OBJECTIVES: 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 ...
Eligibility Criteria
Inclusion
- Life-threatening marrow failure of nonmalignant etiology meeting two of the three following criteria: granulocytes \< 500/mm\^3; a corrected reticulocyte count \< 1%; platelet count \< 20,000/mm\^3
- Failure to respond to the best available immunosuppressive treatment protocol by 75 days after initiation of therapy
- Lack of an HLA-identical family member or closely matched (9 or 10 of 10 HLA-locus match) unrelated marrow donor
- DONOR: Unrelated UCB unit matched for at least 4 of 6 loci
- DONOR: Related UCB unit matched for at least 3 of 6 lock
- Selection of the UCB unit(s) will be based upon matching or mismatching at HLA-A, B antigen level and DRB1 allele level typing; while HLA-C antigen/allele and HLA-DQB1 antigen/allele level typing are not considered in the matching criteria, if available each may be used to optimize unit selection
- Multiple UCB units are allowed to provide sufficient cell dose; when multiple units are selected, the following rules apply: a) the UCB unit with the least HLA disparity will be selected first (i.e., selection priority is 6/6 match \> 5/6 match \> 4/6 match), additional UCB units may be selected to increase cell dose; b) UCB units must be matched to each other for at least 4 of 6 loci; c) each unit must contain at least 1.5 x 10\^7 Total Nucleated Cells per kg recipient weight; d) the total cell dose of the combined units must be at least 3.0 x 10\^7 Total Nucleated Cells per kg recipient weight
Exclusion
- Severe disease other than aplastic anemia that would severely limit the probability of survival during the graft procedure; patients who present with active fungal infections must be treated to resolve this problem before beginning the conditioning regimen
- HIV seropositive patients
- Patients who have developed clonal cytogenetic abnormalities or a myelodysplastic syndrome (these patients will be considered in separate protocols for myelodysplastic syndrome, etc.)
- Patients with paroxysmal nocturnal hemoglobinuria or Fanconi anemia
- Patients \> 40 years of age
- Related or unrelated cord blood units with \< 1.5 x 10\^7 Total Nucleated Cells per kg recipient weight
- Related or unrelated cord blood units without full testing and negative results for hepatitis A, B, C, HIV, HTLV-1, CMV viruses
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00354419
Start Date
February 1 2006
Last Update
January 5 2011
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109