drugset
drugset / Trial / NCT01164475

Evaluation of Approved Weight-Based Dose Compared to Fixed Dose of Plerixafor in Patients With Non-Hodgkin's Lymphoma (NHL) Weighing Less Than 70 Kilograms

NCT01164475 ↗

Phase 4 Completed 61 enrolled Genzyme, a Sanofi Company
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to compare the responses of 2 different doses of plerixafor in patients with Non-Hodgkin's Lymphoma (NHL) who received an autologous stem cell transplant.

Timeline

Start
2010-10
Primary completion
2013-02
Completion
2013-02

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Fixed Dose Plerixafor vs Weight-Based Plerixafor; p = 0.395; Odds Ratio (OR) 1.91 (95% CI 0.44 to 9.17); Regression, Logistic NCT01164475 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Plerixafor Small molecule 0.24 mg/kg Subcutaneous
Subject Plerixafor Small molecule 20 mg Subcutaneous
Background Granulocyte-colony stimulating factor (G-CSF) Protein / enzyme biologic 10 ug/kg Subcutaneous

Indications

non-Hodgkin lymphoma