Conditions: Leukemia, Myeloid, Chronic Anemia, Aplastic Myelofibrosis Lymphoma Hodgkin Disease Leukemia, Lymphocytic, Chronic Leukemia, Myelocytic, Acute Leukemia, Lymphocytic, Acute
Keywords: Myelogenous Leukemia, Chronic Myelodysplasia Parathyroid Hormone Umbilical Cord Blood Stem Cell Transplantation
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 13
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Parathyroid hormone after double umbilical cord blood transplant.

Interventions: intervention 1: Parathyroid Hormone (teriparatide)
Intervention descriptions: intervention 1: 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

Protocol document: