The purpose of this study is to determine whether the addition of parathyroid hormone after a sequential cord blood transplant will improve engraftment, which is the ability of the transplanted stem cells to grow and to successfully begin producing new blood cells.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
13
Day +1: PTH 40 mcg, Day +2: PTH 60 mcg, Day +3: PTH 80 mcg, Day +4 to Day +29 or until ANC\>2000/microL: PTH 100 mcg
University of Florida
Gainesville, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
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)
Time frame: Statistic is calculated at Day 42 but ANC counts are measured daily up through discharge.
Cumulative Incidence of Acute GVHD Grades II-IV at Day 100
Cumulative Incidence of Acute GVHD Grades II-IV at day 100
Time frame: Measured at Day 100
Cumulative Incidence of Chronic GVHD
Cumulative Incidence of Chronic GVHD
Time frame: Measured at 2 years
Platelet Engraftment (Greater Than 20,000)
Platelet engraftment (greater than 20,000)
Time frame: Measured at Day 180
100-day Transplant-related Mortality
100-day transplant-related mortality
Time frame: Measured at Day 100
Cumulative Incidence of Relapse
Cumulative Incidence of Relapse
Time frame: Measured at 2 years
Overall Survival
Overall Survival
Time frame: Measured at 2 years
Disease-free Survival
Disease-free survival
Time frame: Measured at 1 year
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