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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
MD Anderson Cancer Center
Houston, Texas, United States
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).
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