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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00354419
Date of registration: 19/07/2006
Prospective Registration: Yes
Primary sponsor: Fred Hutchinson Cancer Research Center
Public title: Cyclophosphamide, Antithymocyte Globulin, and Total-Body Irradiation in Treating Patients With Severe Aplastic Anemia Undergoing Umbilical Cord Blood Transplant
Scientific title: A Dose Finding Study of Total Body Irradiation for Conditioning Patients With Severe Aplastic Anemia Transplanted With Umbilical Cord Blood
Date of first enrolment: February 2006
Target sample size: 30
Recruitment status: Terminated
URL:  http://clinicaltrials.gov/show/NCT00354419
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Ann Woolfrey
Address: 
Telephone:
Email:
Affiliation:  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: N/A
Age maximum: 40 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Aplastic Anemia
Intervention(s)
Biological: anti-thymocyte globulin
Biological: filgrastim
Drug: cyclophosphamide
Drug: cyclosporine
Drug: mycophenolate mofetil
Genetic: DNA analysis
Procedure: bone marrow aspiration
Procedure: umbilical cord blood transplantation
Radiation: total-body irradiation
Primary Outcome(s)
Toxicity [Time Frame: Yes]
Secondary Outcome(s)
Engraftment [Time Frame: No]
Secondary ID(s)
2030.00
NCI-2010-00191
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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