drugset / Trial / NCT00241358

Study Evaluating AMD3100 for Transplantation of Sibling Donor Stem Cells in Patients With Hematological Malignancies

NCT00241358 ↗

Phase 1/2 Completed 92 enrolled Washington University School of Medicine
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients.

Timeline

Start
2004-05
Primary completion
2009-12
Completion
2010-02

Outcome

Missed primary endpoint

paper The primary outcome of reducing the failure to collect ≥2 × 106 CD34+/kg recipient weight in 1 apheresis collection to ≤10% was not reached. PMID 28292947 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject AMD3100 Small molecule 80 ug/kg Subcutaneous
Subject AMD3100 Small molecule 240 ug/kg Subcutaneous
Subject AMD3100 Small molecule 480 ug/kg Subcutaneous