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The purposes of this study are:
Full description
This study is a single-arm, non-randomized feasibility study. Patients meeting the criteria for this study will be entered sequentially until completion or closure of the study. Early stopping rules will be employed to ascertain whether an unacceptable rate of toxicity (non-engraftment, and/or acute GVHD) occurs.
Patients will be prepared for transplant through the administration of the following conditioning regimen based on their primary disease:
Enrollment
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Inclusion criteria
Patients with hematologic malignancies or bone marrow failure syndrome who are candidates for allogeneic bone marrow transplantation are eligible for this study. Hematologic malignancies indicated for transplantation:
Patients who do not have a 6 out of 6 matched related or unrelated donor or 4/6 and 5/6 matched cord blood will be eligible for this study.
Partially mismatched related donor availability as defined by molecular typing with 3 to 5 HLA matches.
Patients who are under 22 years of age.
Exclusion criteria
Patients will not be excluded based on sex, racial, or ethnic background.
Patients will be excluded if they demonstrate significant functional deficits in major organs, which would obviously interfere with successful outcome following bone marrow transplant utilizing the following guidelines.
Patients will be excluded if they are women of childbearing potential who are currently pregnant (beta-HCG+) or who are not practicing adequate contraception.
Patients who have had a previous hematopoietic stem cell transplant will be excluded.
Donors will be excluded if they are sensitive to E. coli-derived protein.
Primary purpose
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8 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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