NCT00299780

Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization.

Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (planned)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphoma
• Multiple Myeloma
• Acute Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	Stem cell mobilization

Timeline

• Start date: 2004-07-01
• Completion: 2007-04-01
• First posted: 2006-03-07
• Last updated: 2007-04-24

Locations

3 sites across 1 country: United States