A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve CLL or SLL
|ClinicalTrials.gov Identifier: NCT02264574|
Recruitment Status : Active, not recruiting
First Posted : October 15, 2014
Last Update Posted : January 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Small-Cell Lymphoma||Drug: Ibrutinib Drug: Obinutuzumab Drug: Chlorambucil||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||212 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Multi-center, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||January 2020|
Oral ibrutinib 420 mg daily (3 capsules) continuously (until evidence of progressive disease or no longer tolerated by the patient) in combination with obinutuzumab 1000 mg intravenously over 6 cycles: Days 1+2 (100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of Cycle 1 followed by Day 1 only on Cycles 2-6..
Ibrutinib will be supplied as 140 mg hard gelatin capsules for oral (PO) administration.Drug: Obinutuzumab
Obinutuzumab will be supplied as 1000 mg/40 mL solution in a single-use vial for intravenous (IV) administration
Treatment will be 6 cycles. Chlorambucil will be administered orally at a dose of 0.5 mg/kg body weight, on Days 1 and 15 of each cycle. Obinutuzumab will be administered intravenously at a dose of 1000 mg, over 6 cycles: given on Days 1+2 (100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of Cycle 1 and on Day 1 only on Cycles 2-6. Treatment will be administered up to a maximum of 6 cycles or until disease progression or unacceptable toxicity, whichever occurs first.
Obinutuzumab will be supplied as 1000 mg/40 mL solution in a single-use vial for intravenous (IV) administrationDrug: Chlorambucil
Chlorambucil will be supplied as 2 mg film-coated tablets for oral (PO) administration
- The primary endpoint of this study is Progressive Free Survival [ Time Frame: 5 years after last subject is randomized ]The efficacy of ibrutinib in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab based on the IRC assessment compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression-free survival (PFS) in subjects with treatment-naive chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)by independent central radiologists, findings from physical examinations and hematology results
- Overall Response Rate [ Time Frame: At disease progression, 5 years ]Overall response rate (ORR) is defined as the proportion of subjects who achieve a CR, CRi, nPR, or PR, over the course of the study as evaluated by the IRC using IWCLL 2008 criteria, with modification for treatment-related lymphocytosis. Subjects who do not have any postbaseline response assessment will be considered as nonresponders. A chi-square test will be used to compare the two treatment arms
- Rate of minimal residual disease (MRD)-negative responses [ Time Frame: At disease progression, 5 years ]A chi-square test will be used to compare the rate of MRD-negative responses between the two treatment arms.
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): NCT02264574
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