A Randomized Phase Iii Study Of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone In Untreated Older Patients (≥ 65 Years Of Age) With Chronic Lymphocytic Leukemia (CLL)
March 15, 2015
Cancer - Leukemia
Syed Ali, MD
- D’Amour Center for Cancer Care, 3350 Main Street, Springfield, MA
- Baystate Franklin Medical Center, 164 High Street, Greenfield, MA
The purpose of this study is to compare the effects, good and/or bad, of the drug ibrutinib, either alone or in combination with the drug rituximab, with the standard treatment for this disease.
Diagnosis of Chronic Lymphocytic Leukemia (CLL); no prior treatment.
• Patient must be eligible for the core CLC.2/A041202 protocol.
• Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
• Patient must be able (i.e. sufficiently fluent), and willing to complete the health utilities questionnaire in English or French. The baseline assessment must be completed within required timelines, prior to registration/randomization Inability (illiteracy in English or French, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the core protocol. However, ability but unwillingness to complete the questionnaires will make the patient ineligible for the core protocol.
• Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.