Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

Phase 3 Recruiting 60000 enrolled Center for International Blood and Marrow Transplant Research National Marrow Donor Program · collab

NaSingle-groupOpen-labelOther

Summary

The purpose of the study is to: * Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from National Marrow Donor Program donors (NMDP) donors * Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis * Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor hematopoietic stem cell transplant recipients * Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in normal donors

Timeline

Start: 1997-02
Primary completion: 2030-01
Completion: 2030-01

Publications

Pulsipher MA, Chitphakdithai P, Logan BR, Leitman SF, Anderlini P, Klein JP, Horowitz MM, Miller JP, King RJ, Confer DL. Donor, recipient, and transplant characteristics as risk factors after unrelated donor PBSC transplantation: beneficial effects of higher CD34+ cell dose. Blood. 2009 Sep 24;114(13):2606-16. doi: 10.1182/blood-2009-03-208355. Epub 2009 Jul 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	filgrastim	Protein / enzyme biologic	10 ug/kg	Subcutaneous

Indications

No indication recorded.