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

PHASE3CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Chronic Lymphocytic Leukemia (CLL)
Interventions
DRUG

Dinaciclib

Dinaciclib administered intravenously over 2 hours at a dose of 7 mg/m\^2 on Day 1, 10 mg/m\^2 on Day 8, and 14 mg/m\^2 on Day 15 in Cycle 1. Starting in Cycle 2 and thereafter, dinaciclib will be dosed at 14 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle for a total of 12 cycles.

DRUG

Ofatumumab

Ofatumumab administered intravenously at a dose of 300 mg on Cycle 1 Day 1, followed by 2000 mg on Cycle 1 Days 8, 15, and 22; Cycle 2 Days 1, 8, 15, and 22; followed 5 weeks later on Day 1 of Cycles 4-12.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01580228 - A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714) | Biotech Hunter | Biotech Hunter