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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:  NCT00317876
Date of registration: 24/04/2006
Prospective Registration: No
Primary sponsor: Fred Hutchinson Cancer Research Center
Public title: Cyclophosphamide in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Fanconi's Anemia
Scientific title: Dose-Finding Study for Cyclophosphamide as Conditioning Regimens for Bone Marrow Transplantation From Related Donors in Patients With Fanconi Anemia
Date of first enrolment: June 1998
Target sample size: 25
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00317876
Study type:  Interventional
Study design:  Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
Brazil United States
Contacts
Name:     Hans-Peter Kiem, MD
Address: 
Telephone:
Email:
Affiliation:  Fred Hutchinson Cancer Research Center
Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Diagnosis of Fanconi's anemia by chromosome fragility with a diepoxybutane (DEB) or
mitomycin C test

- Hemoglobin = 8.0 g/dL, absolute granulocyte count = 1,000/mm^3, or platelet
count = 50,000/mm^3

- No refractory anemia with excess blasts, refractory anemia with excess blasts in
transformation, or acute leukemia

- HLA-identical related donor available

PATIENT CHARACTERISTICS:

- Glomerular filtration rate = 30% predicted for age

- No liver disease (e.g., active hepatitis or moderate to severe portal
fibrosis/cirrhosis by biopsy)

- No symptomatic cardiac insufficiency or symptomatic arrhythmia

- No other diseases that would severely limit the probability of survival

- No HIV seropositivity

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- Not specified



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Fanconi Anemia
Intervention(s)
Drug: cyclophosphamide
Drug: cyclosporine
Drug: methotrexate
Procedure: allogeneic bone marrow transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Primary Outcome(s)
Conditioning-related toxicity [Time Frame: 100 days post-transplant]
Graft rejection [Time Frame: 100 days post-transplant]
Secondary Outcome(s)
Secondary ID(s)
1288.00
CDR0000481264
FHCRC-1288.00
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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