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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: 16 December 2017
Main ID:  NCT00343785
Date of registration: 22/06/2006
Prospective Registration: Yes
Primary sponsor: Fred Hutchinson Cancer Research Center
Public title: Cyclophosphamide and Anti-thymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing Donor Bone Marrow Transplant
Scientific title: Cyclophosphamide and Antithymocyte Globulin Conditioning Regimen for Marrow Transplantation From HLA-Matched Family Members for Severe Aplastic Anemia: Effect of Marrow Cell Dose on Chronic Graft-vs.-Host Disease: A Multi-Center Trial
Date of first enrolment: February 2006
Target sample size: 21
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00343785
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Canada United States
Contacts
Name:     Rainer Storb
Address: 
Telephone:
Email:
Affiliation:  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Key inclusion & exclusion criteria

Inclusion Criteria:

- Any patient who has aplastic anemia with marrow failure involving 2 of the three
following criteria: granulocytes < 500/uL; a corrected reticulocyte count of < 1%;
platelet count of < 20,000/uL

- Availability of an human leukocyte antigen (HLA)-matched family member

- DONOR: Family member who is HLA-matched

- DONOR: If more than one HLA-matched family member is available, priority will be given
to a donor who is genotypically HLA-identical, of appropriate cytomegalovirus (CMV)
serology, ABO compatible, and, in case of a female donor, non-parous

Exclusion Criteria:

- Severe disease other than aplastic anemia that would severely limit the probability of
survival during the graft procedure:

- Patients who have developed clonal cytogenetic abnormalities or myelodysplastic
syndrome (preleukemia)

- Patients with Fanconi's anemia

- Aplasia secondary to radiation or cytotoxic chemotherapy

- Patients with paroxysmal nocturnal hemoglobinuria who have not developed aplastic
anemia

- Severe organ toxicities:

- Cardiac insufficiency requiring treatment or symptomatic coronary artery disease;

- Severe hypoxemia , partial pressure of oxygen (pO2) < 70 mm Hg, with decreased
diffusion capacity of carbon monoxide (DLCO) < 70% of predicted; or mild
hypoxemia, pO2 < 80 mm Hg with severely decreased DLCO < 60% of predicted;

- Impaired renal function (creatinine > 2 times upper limit of normal or estimated
creatinine clearance < 60 ml/min)

- Fungal infections with radiological progression after receipt of amphotericin B or
active triazole for greater than 1 month

- Human immunodeficiency virus (HIV)-positive patients

- Females who are pregnant or breast-feeding

- DONOR: Donors who have increase anesthetic risk and are not able psychologically and
medically to tolerate the procedure

- DONOR: HIV-positive donors



Age minimum: N/A
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Aplastic Anemia
Intervention(s)
Biological: anti-thymocyte globulin
Drug: cyclophosphamide
Drug: cyclosporine
Drug: methotrexate
Genetic: DNA analysis
Genetic: polymorphism analysis
Other: flow cytometry
Other: laboratory biomarker analysis
Procedure: allogeneic bone marrow transplantation
Primary Outcome(s)
Incidence of Chronic GVHD [Time Frame: 2 years]
Secondary Outcome(s)
Number of Days to Neutrophil Recovery to >500/uL [Time Frame: 100 days post-transplant]
Overall Survival [Time Frame: From the time of enrollment until death from any cause up to one year]
Secondary ID(s)
2054.00
NCI-2010-01781
P01HL036444
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Heart, Lung, and Blood Institute (NHLBI)
Ethics review
Results
Results available: Yes
Date Posted: 16/03/2017
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00343785
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