Trials / Terminated
TerminatedNCT00393380
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- The Emmes Company, LLC · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Leukemia, Myeloid, Chronic
- Anemia, Aplastic
- Myelofibrosis
- Lymphoma
- Hodgkin Disease
- Leukemia, Lymphocytic, Chronic
- Leukemia, Myelocytic, Acute
- Leukemia, Lymphocytic, Acute
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Parathyroid Hormone (teriparatide) | 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 |
Timeline
- Start date
- 2006-09-01
- Primary completion
- 2009-11-01
- Completion
- 2012-03-01
- First posted
- 2006-10-27
- Last updated
- 2013-04-29
- Results posted
- 2012-12-07
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00393380. Inclusion in this directory is not an endorsement.