Combination Study of IPH2201 (Monalizumab) With Ibrutinib in Relapsed, Refractory or Previously Untreated CLL

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

November 9, 2015

Primary Completion Date

October 29, 2018

Study Completion Date

September 25, 2019

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

monalizumab

"During phase 1, patients received monalizumab, IV, at the dose of 1, 2 or 4mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.~During phase 2, patients received monalizumab, IV, at the dose recommended upon completion of phase 1, combined with ibrutinib 420 mg orally, once daily, from the first cycle, during 52 weeks. In both parts of the trial, the first 4 administrations of monalizumab (from week 0 to week 6) occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks."

Trial Locations (1)

43210

The Ohio State University Wexner Medical Center, Columbus

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Innate Pharma

INDUSTRY