Lenalidomide and Obinutuzumab for Previously Untreated CLL

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

February 28, 2018

Primary Completion Date

December 31, 2019

Study Completion Date

December 31, 2022

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

Lenalidomide

"Lenalidomide is administered orally once daily on Days 8-28 of each 28 day cycle. The starting dose for all patients is 5 mg PO daily. At the start of each cycle, there is intra-patient dose-escalation to a maximum of 25mg daily, as tolerated.~The study consists of a 6 month treatment period with obinutuzumab and lenalidomide, and an indefinite period of treatment with lenalidomide for as long as it is helpful and tolerated by subject."

DRUG

Obinutuzumab

Obinutuzumab is administered as follows: Cycle 1: 100mg IV on day 1, 900 mg IV on day 2, 1000mg day 8, 1000 mg on day 15. Cycles 2-6: 1000mg IV on day 1.

Trial Locations (1)

92093

UC San Diego Moores Cancer Center, La Jolla

Sponsors
All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

collaborator

Genentech, Inc.

INDUSTRY

lead

University of California, San Diego

OTHER