Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor (NCT01350245) | Clinical Trial Compass
CompletedPhase 2
Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor
United States28 participantsStarted 2010-07
Plain-language summary
The primary hypothesis of this research study is that patients in remission undergoing myeloablative haploidentical hematopoietic stem cell transplantation (HSCT) on the Thomas Jefferson University (TJU) 2 Step treatment regimen will have a disease-free survival (DFS) rate at 1 year that is the same or better than the historical DFS of patients with similar diagnoses and ages undergoing matched sibling HSCT. Based on a review of the literature a DFS rate of 50% or better at 1 year would meet the criterion for an effective alternative therapy. A DFS rate of 75% or better would imply superior efficacy of the TJU 2 Step approach over T-replete matched sibling HSCT.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Any patient with a hematologic or oncologic diagnosis without morphological evidence of disease in which allogeneic HSCT is thought to be beneficial.
✓. Patients must have a related donor who is a two or more allele mismatch at the HLA-A; B; C; DR loci.
✓. Patients must adequate organ function:
✓. Performance status \> or = 70% (TJU Karnofsky)
✓. HCT-CI Score \< 5 Points
✓. Patients must be willing to use contraception if they have childbearing potential
✓. Able to give informed consent
Exclusion criteria
✕. Performance status \< or = 70% (TJU Karnofsky)
✕. HCT-CI Score \> 5 Points
✕. Combination of Performance status of \< 80% (TJU Karnofsky) and an HCT-CI of 4 points or more.
What they're measuring
1
Disease-Free Survival (DFS)
Timeframe: 1 year post-transplant
2
Probability of Overall Survival at 15 Months Post-treatment
Timeframe: 15 months
Trial details
NCT IDNCT01350245
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University