A Randomized Study of Combined Haplo-identical Umbilical Cord Blood Transplantation vs. Double Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies
This is a clinical trial for subjects with hematologic malignancies ( acute myelogenous
leukemia, acute lymphocytic leukemia, Hodgkin's or Non-Hodgkin's lymphoma, or
myelodysplastic syndrome) who are in need of a donor stem cell transplant, and for whom an
umbilical cord blood transplant is thought to be the best option. For allogeneic transplant
donors, we typically try to use related family members, such as brothers or sisters, or
volunteer donors who are 'HLA matched', i.e. share similar proteins on their cells. This
study is for subjects for whom such a matched sibling donor or a matched unrelated donor is
This study tests a new method of bone marrow transplantation called combined haplo-identical
cord (haplo-cord) transplantation. In this procedure, cells from a related donor who shares
half of the HLA proteins ( haplo-identical)are collected from the blood, as well as cells
from an umbilical cord, and then both are transplanted. It is hoped that by using cells from
a haplo-identical relative, subjects will have a faster recovery and require fewer
transfusions. Over time the haplo-identical cells from the relative are replaced by the
cells from the cord blood. The combined transplantation of haplo-identical stem cells and
cord blood has previously been used in approximately 60 subjects with very encouraging
The purpose of this study is to compare the efficacy of haplo-cord transplant (
"investigational" arm) with the more commonly used procedure in which only the cells
contained in one or two umbilical cords are infused ("standard" arm). Subjects will be
randomly assigned into either the haplo-cord group or the umbilical cord group.
If randomized to the haplo-cord group, a family member will undergo a stem cell collection.
In both arms, subjects will receive a "conditioning regimen" prior to transplantation. The
conditioning regimen consists of chemotherapy, which is meant to destroy the cancer cells
and suppress the immune system to allow the transplanted cells to grow. Subjects will remain
in the hospital until the stem cells are fully recovered, which is usually 4 to 6 weeks
after the transplant. Subjects will have bone marrow aspiration and biopsy at 3 weeks, 4
weeks, 2 months, 6 months and 1 year after the transplant and then yearly thereafter.
Participation in the study will continue for up to 5 years after transplantation.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of neutrophil engraftment after combined haplo-identical cord with that of umbilical cord blood transplantation.
estimation of 24 months to determine engraftment rates for all subjects
Koen van Besien, MD, PhD
Weill Medical College of Cornell University
United States: Institutional Review Board
|Weill Cornell Medical College||New York, New York 10021|