Myelodysplastic Syndrome Clinical Trial
Official title:
A Randomized Study of Combined Haplo-identical Umbilical Cord Blood Transplantation vs. Double Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies
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.
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 not available.
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 results.
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.
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