Obinutuzumab With High-dose Ibrutinib for the Treatment of Patients With Chronic Lymphocytic Leukemia With Progressive Disease on Single Agent Ibrutinib.

PHASE1WithdrawnINTERVENTIONAL

Timeline

Start Date

June 30, 2016

Primary Completion Date

November 30, 2019

Study Completion Date

November 30, 2020

Conditions

Chronic Lymphocytic Leukemia

Interventions

DRUG

ibrutinib

Cohort 1 420 mg PO daily Cohort 2 560 mg PO daily Cohort 3 700 mg PO daily Cohort 4 840 mg PO daily

DRUG

obinutuzumab

obinutuzumab 100 mg IV on day 1, 900mg IV on day 2, 1000mg IV day 8, 15, 28 then q 28 days for a total of 8 doses.