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Study record managers: refer to the Data Element Definitions if submitting Mature sex Northern Arm or information. To determine whether progression free survival PFS is superior after therapy with bendamustine bendamustine hydrochloride in combination with rituximab, ibrutinib alone, or ibrutinib in combination with rituximab in patients age 65 or older with ly untreated chronic lymphocytic leukemia CLL. To determine 2-year PFS in each of the three treatment arms. To determine which treatment arm produces superior overall survival OS.
To determine duration of response after each of the three treatments and compare these treatment arms. To determine toxicity and tolerability of the three treatment regimens. To determine whether baseline cytogenetic markers, zeta-chain TCR associated protein kinase 70kDa Zap methylation, immunoglobulin variable region IgVH mutational status, or select deoxyribonucleic acid DNA mutations predict outcomes or time to response in these three arms.
To determine whether local fluorescent in situ hybridization FISH for del 11q To determine whether baseline micro ribonucleic acid RNA and gene expression markers are correlated with clinical outcomes of interest e. To determine whether eradication of MRD predicts longer duration of response with standard therapy and ibrutinib-based regimens. To describe the baseline functional status, comorbid medical conditions, and of medications of older CLL patients who meet criteria for therapy.
To determine whether geriatric assessment variables known to be associated with chemotherapy toxicity in other disease groups can also predict therapy-associated toxicity in the CLL population.
Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive rituximab IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses After completion of study treatment, patients are followed up every 6 months for up to 10 years.
The analysis was event driven, performed at 2. Progression free survival time will be the time to either progression or death whichever occurs first.
Secondary Outcome Measures : Progression Free Survival PFS Rate at 2 Years [ Time Frame: Time from study entry to the time of documented disease progression or death, assessed up to 2 years ] The Kaplan-Meier method will be used to estimate the rate of progression free survival at 2 years in each treatment arm. Overall Survival OS at 2 Years [ Time Frame: From the date of registration to the date of death, assessed up to 2 years ] The Kaplan-Meier method will be used to estimate the rate of overall survival at 2 years in each treatment arm.
OS will be measured from the date of registration to the date of the event i. Patients who are event-free at their last follow-up evaluation will be censored at that time point. DOR is the time from first objective status to progression or death. Talk with your doctor and family members or friends about deciding to a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Patients must be intermediate or high-risk Rai stage CLL. Patients must meet criteria for treatment as defined by IWCLL guidelines which includes at least one of the following criteria:.
Constitutional symptoms, which include any of the following:. Patients with active hepatitis B defined by hepatitis B surface antigen positivity or core antibody positivity in the presence of hepatitis B DNA are not eligible for this study; patients with a positive hepatitis B core antibody but with negative hepatitis B DNA may participate, but must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician.
Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Search for terms. Save this study. Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government.
Read our disclaimer for details. First Posted : December 30, Last Update Posted : September 28, Study Description. This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with ly untreated chronic lymphocytic leukemia.
Monoclonal antibodies, such as rituximab, may block cancer Mature sex Northern Arm in different ways by targeting certain cells. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether rituximab with bendamustine hydrochloride may work better than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia.
Show detailed description. Hide detailed description. Detailed Description:. FDA Resources. Arms and Interventions. Patients receive ibrutinib PO daily. Patients receive ibrutinib as in Arm II. Outcome Measures.
The Kaplan-Meier method will be used to estimate the rate of overall survival at 2 years in each treatment arm. Estimated using the of patients who achieve minimal residual disease divided by the total randomized to that treatment arm. The rate of grade 3, 4, or 5 treatment-related non-hematologic adverse events toxicities by arm; excludes adverse events occurring post-crossover for patients in Arm A. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Contacts and Locations. Information from the National Library of Medicine 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. More Information. Adverse event burden in older patients with CLL receiving bendamustine plus rituximab or ibrutinib regimens: Alliance A N Engl J Med.
Epub Dec 1. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Phase 3. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Actual Study Start Date :. Actual Primary Completion Date :. Active Comparator: Arm I rituximab, bendamustine hydrochloride Patients receive rituximab IV on day 1 day 0 course 1 and bendamustine hydrochloride IV over 30 minutes on days Woodland Hills, California, United States, Colorado Springs, Colorado, United States, Greenwood Village, Colorado, United States, Washington, District of Columbia, United States, Altamonte Springs, Florida, United States, Hinsdale Hematology Oncology Associates Incorporated.
Springfield, Massachusetts, United States, Clinton Township, Michigan, United States, Farmington Hills, Michigan, United States, Sterling Heights, Michigan, United States, Heartland Hematology and Oncology Associates Incorporated. Sainte Genevieve, Missouri, United States, Greenville, North Carolina, United States, Hendersonville, North Carolina, United States, Jacksonville, North Carolina, United States, Statesville, North Carolina, United States, Warrensville Heights, Ohio, United States, East Stroudsburg, Pennsylvania, United States, Hershey, Pennsylvania, United States,Mature sex Northern Arm
email: [email protected] - phone:(628) 619-6865 x 6012
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