Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization.
The purpose of this study is to determine the safety of parathyroid hormone in combination with G-CSF when used as a stem cell mobilization regimen for patients who fail to mobilize sufficient progenitor stem cells after one or two attempts.
Acute Myelogenous Leukemia
Drug: Stem cell mobilization
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization|
- To assess safety of parathyroid hormone in combination with G-CSF when used as a mobilization agent at four different dosing levels.
- To evaluate the peripheral blood CD34+ count after second mobilization.
- To evaluate CD34+ cells/kg from apheresis after second mobilization.
- To evaluate the percent of patients for whom adequate numbers of CD34+ cells are obtained.
- To evaluate transfusion support.
- To evaluate the days to neutrophil engraftment (ANC >500) post autologous transplant.
- To evaluate the days to platelet engraftment (platelet count > 20,000 unsupported).
|Study Start Date:||July 2004|
|Estimated Study Completion Date:||April 2007|
Patients will start treatment within 21 days of the determination of inadequate mobilization. PTH treatment will be given in 4 cohorts: 40 mcg, 60 mcg, 80 mcg, and 10 mcg. PTH will be given on day 1 and continue until stem cell collections are complete or a maximum of 20 days. G-CSF 10 mcg/kg will be given on days 10-14 and continue until stem cell collections are complete. Patients with inadequate CD34+ cells on Day 14 will meet off study criteria and not continue with PTH/G-CSF.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02116|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Karen Ballen, M.D.||Massachusetts General Hospital, Harvard University|