Haploidentical Donor Hematopoietic Stem Cell Transplant in Treating Patients With Hematologic Mal… (NCT01871441) | Clinical Trial Compass
TerminatedPhase 2
Haploidentical Donor Hematopoietic Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Stopped: Trial was closed due to poor accrual.
United States4 participantsStarted 2013-05-17
Plain-language summary
This phase II trial studies how well haploidentical donor hematopoietic stem cell transplant works in treating patients with hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Giving an infusion of the donor's T cells (donor lymphocyte infusion) may replace the patient's immune cells and help destroy any remaining cancer cells. When the stem cells from a related donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
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 have adequate organ function:
✓. LVEF (Left ventricular ejection fraction) of \>50%
✓. Diffusion Capacity for Carbon Monoxide (DLCO) \>50% of predicted corrected for hemoglobin
✓. Adequate liver function as defined by a serum bilirubin \<1.8, Aspartate Aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5X upper limit of normal
✓. Creatinine clearance of \> 60 ml/min
✓. Performance status \> 80% (TJU Karnofsky)
Exclusion criteria
✕. Performance status \< 80 % (TJU Karnofsky)
✕
What they're measuring
1
Number of Participants With Disease-free Survival (DFS)
Timeframe: 1 year
Trial details
NCT IDNCT01871441
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University