Phase 2 Study of the Combination of Bruton's Tyrosine Kinase Inhibitor PCI-32765 and Rituximab in High-Risk Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Patients
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|ClinicalTrials.gov Identifier: NCT01520519|
Recruitment Status : Completed
First Posted : January 30, 2012
Results First Posted : September 18, 2019
Last Update Posted : September 18, 2019
The goal of this clinical research study is to learn if PCI-32765 (Ibrutinib) combined with rituximab can help to control CLL and SLL. The safety of this combination will also be studied.
Ibrutinib is designed to stop a protein from working in the cells, which may cause the cancer cells to die or stop growing.
Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to die.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Rituximab Drug: PCI-32765||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of the Combination of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 and Rituximab in High-Risk Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) Patients|
|Actual Study Start Date :||February 27, 2012|
|Actual Primary Completion Date :||August 9, 2018|
|Actual Study Completion Date :||August 9, 2018|
Experimental: Rituximab + PCI-32765
Rituximab (375 mg/m2) given intravenously (IV) on Day 1, Day 8, Day 15, and Day 22, then continued once every 4 weeks only on Days 1 during cycles 2 - 6. PCI-32765 started on Day 2 of cycle 1 at a dose of 420 mg (3 * 140-mg capsules) orally daily and will be continued daily.
375 mg/m2 intravenously on Day 1, Day 8, Day 15, and Day 22, then continued once every 4 weeks only on Days 1 during cycles 2 - 6.
Other Name: Rituxan
420 mg (3 * 140-mg capsules) orally started on Day 2 of cycle 1 once daily and will be continued daily.
- Progression Free Survival (PFS) [ Time Frame: up to 50 months ]Progression free survival defined as the time interval from treatment to progressive disease or death, whichever happens earlier. Participants in complete remission (CR), partial remission (PR) or stable disease (SD) are all counted as progression-free. Survival or times to progression functions estimated using the Kaplan-Meier method.
- Number of Participants With a Response [ Time Frame: 7 months ]Over all Response = complete remission (CR) + partial remission (PR). Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; positive or negative minimal residual disease (MRD); Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts
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): NCT01520519
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jan A. Burger, MD||M.D. Anderson Cancer Center|