drugset
drugset / Trial / NCT02557516

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

NCT02557516 ↗

Phase 1/2 Terminated 22 enrolled Innate Pharma
Non-randomizedSequentialOpen-labelTreatment

Summary

Combination study of monalizumab (IPH2201) with Ibrutinib in relapsed, refractory or previously untreated Chronic Lymphocytic Leukemia (CLL) patients in 2 parts : * phase 1 : a 3+3 design to assess the Maximum Tolerated Dose (MTD) * phase 2: to evaluate the anti-leukemic activity of the combination

Timeline

Start
2015-11-09
Primary completion
2018-10-29
Completion
2019-09-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Monalizumab Monoclonal antibody 1 mg/kg Intravenous
Subject Monalizumab Monoclonal antibody 2 mg/kg Intravenous
Subject Monalizumab Monoclonal antibody 4 mg/kg Intravenous
Background Ibrutinib Small molecule 420 mg Oral

Indications

B-cell chronic lymphocytic leukemia