drugset / Trial / NCT01580228

A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714)

NCT01580228

Phase 3 Completed 44 enrolled Merck Sharp & Dohme LLC
RandomizedSingle-groupOpen-labelTreatment

Summary

This study is being conducted to demonstrate the superiority in progression-free survival (PFS) of dinaciclib compared to ofatumumab in chronic lymphocytic leukemia (CLL) participants with del 17p or in the overall population who are refractory to either fludarabine treatment or chemoimmunotherapy.

Timeline

Start
2012-08
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Dinaciclib Small molecule 14 mg/m2 Intravenous
Comparator Ofatumumab Monoclonal antibody 2000 mg Intravenous