A Phase II Study of Parathyroid Hormone Following Sequential Unrelated Cord Blood Transplant
Myeloablative chemotherapy or chemoradiotherapy and allogeneic stem cell transplantation is
an accepted curative therapy for many cancers, leukemias, and genetic disorders. Given the
size of most American families, only 30% of patients will have a matched sibling donor and
although national and international registries exist for volunteer donors approximately 50%
of patients are unable to find a suitably matched unrelated donor in time to proceed to
transplant. It is particularly difficult for African Americans and other minorities to find
matched unrelated donors Umbilical cord blood has been shown to contain sufficient cells to
provide durable engraftment and estimated 70,000 cord blood units are available worldwide,
and can be shipped for immediate use
Despite advances in cord blood transplantation using cord blood units with higher cell doses
and the use of two cord blood transplants, delayed engraftment(particularly platelet
engraftment) and poor immune reconstitution remain major causes of morbidity and mortality
following cord blood transplantation.
In this study, we extend our experience with sequential cord blood transplantation. Patients
who are likely to benefit from an ablative conditioning regime will receive either a well
known myeloablative regimen of fludarabine, cyclophosphamide and total body irradiation or a
reduced intensity regimen of fludarabine/melphalan/thymoglobulin. Following conditioning
patients will receive dual sequential unrelated umbilical cord blood transplants. Tacrolimus
will be combined with MMF for the GVHD prophylaxis regimen. Parathyroid hormone is added to
this regimen in an attempt to improve engraftment.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the time to neutrophil engraftment (defined as ANC >500/μL) among patients receiving parathyroid hormone following sequential unrelated cord blood transplantation.
Variable
No
Karen Ballen, MD
Principal Investigator
Massachusetts General Hospital
United States: Institutional Review Board
05-380
NCT00579722
September 2006
July 2010
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
University of Florida | Gainesville, Florida 32610-0277 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |