A Phase II Study of Parathyroid Hormone Following Myeloablative Sequential Unrelated Cord Blood Transplantation
In this phase II, single stage study, participants will include 40 adults who are candidates
for a hematopoietic stem cell transplant. All participants will undergo a sequential cord
blood transplant using a well-known myeloablative regimen of fludarabine, cyclophosphamide,
and total body irradiation, which is appropriate for those individuals who are likely to
benefit from an ablative regimen. Tacrolimus will be combined with mycophenolate mofetil
(MMF) for the graft-versus-host disease (GVHD) prophylaxis regimen. Parathyroid hormone
(PTH) will be added to this regimen in an attempt to improve engraftment. PTH is an
approved drug with minimal side effects in individuals with osteoporosis; the dose of PTH
has been determined from a phase I study in individuals with hematologic cancer.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500)
Median time to neutrophil engraftment (defined as an absolute neutrophil count [ANC] greater than 500)
Statistic is calculated at Day 42 but ANC counts are measured daily up through discharge.
No
Karen K. Ballen, MD
Principal Investigator
Massachusetts General Hospital
United States: Food and Drug Administration
435
NCT00393380
September 2006
March 2012
Name | Location |
---|---|
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 |