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Teriparatide

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Parathyroid hormone after double umbilical cord blood transplant.

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

Parathyroid Hormone (teriparatide)

Karen K. Ballen, MD

Joseph Antin, MD

David Avigan, MD

Elizabeth J Shpall, MD

Colleen Delaney, MD

Ram Kamble, MD

Katarzyna Jamieson, M.D.

Philip McCarthy, M.D.

Edward Ball, M.D.

Richard Maziarz, M.D.

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 of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor

A Phase II Study of Parathyroid Hormone Following Myeloablative Sequential Unrelated Cord Blood Transplantation

Median time to neutrophil engraftment (defined as an absolute neutrophil count \[ANC\] greater than 500)

Cumulative Incidence of Acute GVHD Grades II-IV at day 100

Platelet engraftment (greater than 20,000)

National Heart, Lung, and Blood Institute (NHLBI)

The Emmes Company, LLC

Parathyroid Hormone (Teriparatide)

Age, Categorical

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

The study was closed prematurely due to early mortality and lack of efficacy.

Adam Mendizabal, Statistician

Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500)

Spots Global Cancer Trial Database for parathyroid hormone (teriparatide)