Reduced Intensity Haploidentical Transplant for Hematological Malignancies
United States34 participantsStarted 2006-09
Plain-language summary
Many patients with hematological malignancies (leukemia, lymphoma, multiple myeloma) cannot undergo hematopoietic stem cell transplantation (HSCT) because they do not have a well matched donor. HSCT from partially matched family donors (haploidentical HSCT) is an option for most patients but has been associated with poor outcomes. This study was designed to test whether using an exact amount of a donor's lymphocytes (white cells) and dividing the transplant process into 2 steps, would increase overall survival by decreasing complications. The therapy is reduced intensity so it is targeted, but not limited to, patients over the age of 65 or those who have had previous transplants.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Any patient with a hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied.
✓. Patients must have a related donor who is a two or more allele mismatch at the HLA-A;B; C; DR loci.
✓. Patients who have sibling donors with a one antigen mismatch due to recombination will not be enrolled in this protocol.
✓. Patients must adequate organ function:
✓. LVEF of \>45%
✓. DLCO \>45% of predicted corrected for hemoglobin
✓. Adequate liver function as defined by a serum bilirubin \<1.8, AST or ALT \< 2.5X upper limit of normal
✓. Serum creatinine \< 2.0 mg/dl or creatinine clearance of \> 40 ml/min
Exclusion criteria
✕. Performance status of \< 70% (Karnofsky)
✕
What they're measuring
1
Overall Survival at 6 Months Post-transplant in Patients Receiving a Partially-matched Related Donor Allogeneic Transplant After Reduced-intensity Conditioning
Timeframe: 6 months
Trial details
NCT IDNCT01162096
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
✕. Active involvement of the central nervous system with malignancy
✕. Psychiatric disorder that would preclude patients from signing an informed consent
✕. Pregnancy
✕. Patients with life expectancy of \< 6 months for reasons other than their underlying hematologic/oncologic disorder or complications there from.
✕. Patients who have received alemtuzumab within 8 weeks of transplant admission, or who have recently received horse or rabbit anti-thymocyte globulin and have ATG levels of \> 2 µgm/ml.