drugset / Trial / NCT02200848

Phase I Study of Lenalidomide, Rituximab and Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

NCT02200848

NaSingle-groupOpen-labelTreatment

Summary

This study is for subjects diagnosed with recurrent or relapsed CLL/SLL. The purpose of this study is to test the safety of the combination of the drugs lenalidomide and ibrutinib at different dose levels, in combination with the drug rituximab. We want to find out what effects, good and/or bad, they have on patients with CLL/SLL. The hypothesis of the study is that it will be safe to give the three drugs in combination and the information learned from this trial will be used to study the 3 drug combination is a larger future trial.

Timeline

Start
2014-04
Primary completion
2017-03-27
Completion
2017-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule 280 mg
Subject Ibrutinib Small molecule 420 mg
Subject Lenalidomide Other / unclassified 2.5 mg
Subject Lenalidomide Other / unclassified 5 mg
Subject Lenalidomide Other / unclassified 10 mg
Subject Lenalidomide Other / unclassified 15 mg
Background Rituximab Monoclonal antibody 375 mg/m2