This research study is evaluating a combination of two drugs, ibrutinib and obinutuzumab, as a possible treatment for Chronic Lymphocytic Leukemia (CLL).
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the best order of administration of these two drugs. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has approved ibrutinib and obinutuzumab individually for the treatment of patients with Chronic Lymphocytic Leukemia, your type of cancer. However, the FDA has not approved the combination of these two drugs as a treatment for any disease. Ibrutinib is a type of drug called a kinase inhibitor. It is believed to block a type of protein called a kinase that helps leukemia cells live and grow. By blocking this, it is possible that the study drug will kill cancer cells or stop them from growing. Obinutuzumab is a type of drug called a monoclonal antibody. It is believed to attach to a protein called CD20 on the outside of a Chronic Lymphocytic Leukemia cell. By attaching to the cell, the antibody can cause the Chronic Lymphocytic Leukemia cell to die. In this research study, the investigators are assessing the safety of various dosing regimens of ibrutinib and obinutuzumab. The investigators are trying to determine whether it is better to give one drug before the other or if they can be started at the same time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Obinutuzumab given weekly during cycle 1, then monthly during cycles 2-6
Ibrutinib given once daily by mouth
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Rochester Wilmot Cancer Inst.
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Grade 3-5 Treatment-related Toxicity Rate
All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.
Time frame: AE evaluated at cycle 1 day day 1, 2, 8 and 15; cycle 2 day 1, 8, 15 and 22; then each cycle day 1 until end of treatment.
Overall Response Rate (ORR)
The overall response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on Chronic Lymphocytic Leukemia (IW-CLL) criteria.
Time frame: Disease screening at baseline, cycle 3-7 at day one and end of treatment or disease progression (PD). Median (range) duration of treatment is 29.9 (range 0.5, 98.1) months.
Partial Response Rate (PRR)
The PRR was defined as the proportion of participants achieving partial response (PR) based on Chronic Lymphocytic Leukemia (IW-CLL) criteria.
Time frame: Disease screening at baseline, cycle 3-7 at day one and end of treatment or disease progression (PD). Median (range) duration of treatment is 29.9 (range 0.5, 98.1) months.
Complete Response Rate (CRR)
The CRR was defined as the proportion of participants achieving complete response (CR) based on Chronic Lymphocytic Leukemia (IW-CLL) criteria.
Time frame: Disease screening at baseline, cycle 3-7 at day one and end of treatment or disease progression (PD). Median (range) duration of treatment is 29.9 (range 0.5, 98.1) months.
Minimal Residual Disease (MRD) Rate
MRD rate was defined as the proportion of participants achieving MRD in bone marrow
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Time frame: Disease screening at baseline, cycle 3-7 at day one and end of treatment or disease progression (PD).
Median Progression-Free Survival (PFS)
Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last dsease assessment.
Time frame: Through final follow-up visit (up to 9.63 years).