Lenalidomide and Obinutuzumab for Previously Untreated CLL
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|ClinicalTrials.gov Identifier: NCT02371590|
Recruitment Status : Withdrawn (Study Not Activated Due to Contract Issues)
First Posted : February 25, 2015
Last Update Posted : February 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Lenalidomide Drug: Obinutuzumab||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Clinical Trial To Evaluate Lenalidomide And Obinutuzumab For The Treatment Of Patients With Not Previously Treated Chronic Lymphocytic Leukemia|
|Estimated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2022|
All patients receive the combination of lenalidomide and obinutuzumab. There is no randomization or comparator arm.
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.
Other Name: Revlimid
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.
Other Name: Gazyva
- The incidence of dose limiting toxicity [ Time Frame: 1 year ]For phase 1 portion of study
- Complete Response Rate [ Time Frame: 2 years ]For phase 2 portion of study: iwCLL 2008 defined complete response rate
- Number of patients with adverse events associated with lenalidomide-obinutuzumab [ Time Frame: 2 years ]
- Progression free survival rate [ Time Frame: 2 years ]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
- Overall response rate [ Time Frame: 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371590
|United States, California|
|UC San Diego Moores Cancer Center|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Michael Choi, MD||UC San Diego Moores Cancer Center|