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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00578643 |
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Date of registration:
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19/12/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Matched Unrelated or Non-Genotype Identical Related Donor Transplantation For Chronic Granulomatous Disease
MUNCHR |
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Scientific title:
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HLA Matched Unrelated or Non-Genotype Identical Related Donor Transplantation For Chronic Granulomatous Disease |
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Date of first enrolment:
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March 2004 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00578643 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Robert Krance, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Baylor College of Medicine |
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Key inclusion & exclusion criteria
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INCLUSION CRITERIA:
CGD patients as documented by an abnormal NBT assay in a male patient and/or abnormal NADPH
enzyme mutation confirmed by genetic analysis with abnormal NBT.
Patients must not have an HLA genotype identical donor.
Patients must have a 5/6 or 6/6 HLA-matched unrelated donor or a 5/6 or 6/6 HLA
phenotype-matched related donor.
Patients must have had at least one serious infection characteristic of those manifested in
patients with CGD.
Patients must not have active infection. An active infection may include the following: 1)
clinical findings consistent with an infection such as fever, cavitary organ lesions,
osteomyelitis; 2) progression of presumed infection based upon findings of diagnostic
imaging (two or more studies at least 1 month a part).
No cumulative organ dysfunction that, in the estimation of the treating physicians, will
diminish the patient's likelihood to survive this procedure.
Negative pregnancy test for post-pubertal female patients.
Echocardiogram shortening fraction >/= 28%.
DLCO 50% or greater predicted or FEV1 >/= 50% predicted.
EXCLUSION CRITERIA:
Active or uncontrolled infection (e.g. lung infection, cavitary organ lesions,
osteomyelitis).
Markedly elevated C reactive protein or sedimentation rate relative to patient's baseline.
Invasive bone or bone marrow disease.
Lack of potential hematologic blood product donors in the past (related to McLeod
phenotype).
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Granulomatous Disease
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Intervention(s)
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Drug: Cyclosporine
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Drug: Fludarabine
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Procedure: Stem Cell Infusion
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Drug: Busulfan
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Biological: Alemtuzumab
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Drug: Cyclophosphamide
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Primary Outcome(s)
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Percentage of Participants With Engraftment
[Time Frame: 28 days post transplant]
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Secondary Outcome(s)
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Number of Patients That Have Acute GVHD and Regimen Related Morbidity/Mortality Post Transplant.
[Time Frame: Assessed between day 0 and day 100 post transplant]
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Number of Patients That Have Complete Donor Chimerism After Transplant.
[Time Frame: 120 days post transplant]
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Number of Patients That Have Chronic GVHD and Regimen Related Morbidity/Mortality Post Transplant.
[Time Frame: Assessed between day 100 and day 365 post transplant]
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Secondary ID(s)
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14771-MUNCHR
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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