Cyclophosphamide, Antithymocyte Globulin, and Total-Body Irradiation in Treating Patients With Severe Aplastic Anemia Undergoing Umbilical Cord Blood Transplant
NCT ID: NCT00354419
Last Updated: 2011-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
30 participants
INTERVENTIONAL
2006-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I
See Detailed Description
total-body irradiation
Undergo radiotherapy
cyclophosphamide
Given IV
anti-thymocyte globulin
Given IV
cyclosporine
Given IV
umbilical cord blood transplantation
Undergo transplantation
mycophenolate mofetil
Given IV or orally
bone marrow aspiration
Correlative study
DNA analysis
Correlative study
filgrastim
Given IV or SC
Interventions
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total-body irradiation
Undergo radiotherapy
cyclophosphamide
Given IV
anti-thymocyte globulin
Given IV
cyclosporine
Given IV
umbilical cord blood transplantation
Undergo transplantation
mycophenolate mofetil
Given IV or orally
bone marrow aspiration
Correlative study
DNA analysis
Correlative study
filgrastim
Given IV or SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
40 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Principal Investigators
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Ann Woolfrey
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2010-00191
Identifier Type: -
Identifier Source: secondary_id
2030.00
Identifier Type: -
Identifier Source: org_study_id
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