Bendamustine and Rituximab Induction Therapy and Maintenance Rituximab and Lenalidomide in Previously Untreated CLL/SLL
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|ClinicalTrials.gov Identifier: NCT01754857|
Recruitment Status : Recruiting
First Posted : December 21, 2012
Last Update Posted : October 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lymphoid Leukemia Small Lymphocytic Lymphoma Lymphoma, Non-Hodgkin||Drug: Bendamustine Drug: Rituximab Drug: Lenalidomide||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy Followed by Maintenance Rituximab and Lenalidomide in Previously Untreated Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||November 2021|
Experimental: Bendamustine, rituximab, lenalidomide
INDUCTION: Bendamustine 90 mg/m2 IV D1&2 and rituximab IV D1 (up to day 5 of course 1 only) every 28 days for 6 treatment cycles. Patients achieving objective response proceed to maintenance therapy. Patients with objective response after 4 courses are eligible to proceed to maintenance therapy if ongoing induction therapy is likely associated with unacceptable toxicity.
MAINTENANCE: Beginning 6-12 weeks after completion of induction therapy, patients receive rituximab IV on day 1 of every odd-numbered cycle for 24 cycles; lenalidomide 5-10 mg PO daily on days 1-28 of each cycle (28 day cycles). Patients experiencing excessive toxicity from lenalidomide may continue maintenance therapy with rituximab alone.
Given IVDrug: Rituximab
Given IVDrug: Lenalidomide
- Time to progression [ Time Frame: Up to 30 months ]The primary objective is progression-free survival (PFS). Tumor measurements and disease assessments will be performed at the time of screening, following cycles 3 and 6 of induction chemotherapy, every 4 cycles during the maintenance portion of treatment, and at the end of treatment (EOT). Subjects with clinical evidence of progression prior to a planned disease assessment will be evaluated at the time of clinically suspected progression. Follow-up visits for disease assessment will occur every 3 months after the EOT visit until PD, initiation of alternate anti-neoplastic therapy, decision by the subject to withdraw from the study, or death. The follow-up period will begin after the EOT visit, and all subjects will be followed for at least 2 years after completion of therapy or until death or progression and until the last patient has been followed for at least 1 year following completion of therapy.
- Objective Response Rates [ Time Frame: Up to 30 months ]To determine objective response rates (CR + PR). As described in the primary objective, formal disease assessments including imaging will be performed after cycles 3 and 6 of induction chemotherapy and every 4 cycles during the maintenance portion of treatment. Response and progression in cases of SLL will be evaluated using the International Working Group Criteria30 for response in lymphoma. Response and progression in cases of CLL will be evaluated in this study using the Revised IWCLL Criteria31 for response in CLL. Radiological methodologies, techniques and/or physical examination, established at baseline for the assessment and measurement of each identified lesion will be used for all subsequent assessments.
- Toxicity [ Time Frame: Up to 30 months ]• To determine toxicities observed with induction chemotherapy and maintenance therapy. Safety evaluations will be based on the incidence, intensity, and type of adverse events (AEs) and clinical laboratory results. Drug doses will be modified as required based on toxicity as assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
- Time to Death [ Time Frame: Up to 54 months ]• To determine overall survival. Overall survival will be determined from the date of enrollment until death from any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754857
|Contact: Cancer Connect||(800) firstname.lastname@example.org|
|United States, Wisconsin|
|University of Wisconsin||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Julie Chang, MD 608-263-1836 email@example.com|
|Contact: Erica Stubbendick 608-263-2944 firstname.lastname@example.org|
|Principal Investigator:||Julie Chang, MD||University of Wisconsin, Madison|