This is phase 1/2 study for patients with CLL or (SLL) who have not been previously treated. This study will evaluate whether obinutuzumab and lenalidomide is safe and tolerable in this setting and induce complete clinical responses.
This is phase 1/2 study for patients with CLL or (SLL) who have not been previously treated. The primary endpoint is to determine safety and tolerability of the regimen and determine complete response (CR) to therapy. The secondary endpoints will assess the impact of treatment on progression free and overall survival Eligible patients will receive obinutuzumab for 6 x 28 day cycles. Patients will also receive lenalidomide orally once daily on days 8-28 of each 28 day cycles. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
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.
UC San Diego Moores Cancer Center
La Jolla, California, United States
The incidence of dose limiting toxicity
For phase 1 portion of study
Time frame: 1 year
Complete Response Rate
For phase 2 portion of study: iwCLL 2008 defined complete response rate
Time frame: 2 years
Number of patients with adverse events associated with lenalidomide-obinutuzumab
Time frame: 2 years
Progression free survival rate
Progression free survival rate at completion of combination therapy, total progression free survival, and overall survival determined by International Working Group in CLL (iwCLL) criteria
Time frame: 2 years
Overall response rate
Overall response rate (Complete response + partial response) and stable disease rate (also based on 2008 iwCLL guidelines), also at the time of primary endpoint response assessment.
Time frame: 2 years
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