Randomized HaploCord Blood Transplantation vs. Double Umbilical Cord Blood Transplantation for He… (NCT01745913) | Clinical Trial Compass
TerminatedPhase 2
Randomized HaploCord Blood Transplantation vs. Double Umbilical Cord Blood Transplantation for Hematologic Malignancies
Stopped: Slow accrual
United States2 participantsStarted 2012-10-26
Plain-language summary
The purpose of this study is compare the efficacy of haplo-cord transplant (investigational arm) with that of a more commonly used procedure in which only the cells contained in one or two umbilical cords are infused (standard arm).
We hypothesize that reduced intensity conditioning and haplo-cord transplant results in fast engraftment of neutrophils and platelets, low incidences of acute and chronic graft versus host disease, low frequency of delayed opportunistic infections, reduced transfusion requirements, shortened length of hospital stay and promising long term outcomes. We also hypothesize that umbilical cord blood selection can prioritize matching and better matched donors can be identified rapidly for most subjects.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject must have a histologically or cytologically confirmed diagnosis of: Acute Myelogenous Leukemia Myelodysplastic Syndrome Acute Lymphocytic Leukemia Lymphoma (Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma)
✓. Must be \> 18 years of age
✓. Subject is likely to benefit from allogeneic transplant in the opinion of the transplant physician
✓. An human leukocyte antigen (HLA)-identical related or unrelated donor cannot be identified within an appropriate time frame
✓. Karnofsky Performance Status (KPS) of \> 80
✓. Subject has acceptable organ and marrow function as defined below: Serum bilirubin \< 2.0mg/dL ALT(SGPT) 3 X upper limit of normal Creatinine Clearance \> 50 mL/min as estimated by the modified MDRD equation.18
✓. Ability to understand and the willingness to sign a written informed consent document.
✓. A preliminary search has identified both:
Exclusion criteria
What they're measuring
1
Rate of Neutrophil Engraftment After Combined Haplo-identical Cord With That of Umbilical Cord Blood Transplantation.
Timeframe: estimation of 24 months to determine engraftment rates for all subjects
Trial details
NCT IDNCT01745913
SponsorWeill Medical College of Cornell University