Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL
Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy With Maintenance Lenalidomide and Rituximab in Relapsed/Refractory CLL/SLL
6 other identifiers
interventional
34
1 country
10
Brief Summary
The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2009
Longer than P75 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2009
CompletedFirst Posted
Study publicly available on registry
September 10, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
July 13, 2017
CompletedDecember 2, 2019
July 1, 2017
3.8 years
September 9, 2009
May 17, 2016
November 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression Free Survival
The primary endpoint of this study was progression-free survival (PFS), defined as the number of days from the day of first study drug administration to the day the patient experienced disease progression or death from any cause. Response and progression in cases of small lymphocytic lymphoma(SLL) were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of chronic lymphocytic leukemia (CLL) were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007).
42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Progression-free Survival
Progression-free survival (PFS) is defined as the time from the day of first study drug administration until progression of CLL/SLL or death from any cause. PFS is reported as the proportion of participants with PFS up to 42 months.
42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Secondary Outcomes (3)
Objective Response Rate (Complete + Partial Responses)
42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Overall Survival
42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Study Arms (1)
Induction/Maintenance chemotherapy
EXPERIMENTALBendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
Interventions
90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles
375 mg/m2 Day 1 every 28 days for 6 cycles
5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol.
Eligibility Criteria
You may qualify if:
- Histologically confirmed,CLL/SLL, documented relapsed or refractory disease after at least one prior chemotherapy regimen.
- In cases of SLL, patients must have at least one bidimensionally measurable lesion at least ≥1.5 cm measured in one dimension.
- ECOG performance status of 0-2 at study entry
- Laboratory test results within these ranges: ANC \<=1500/μL, Platelet count \<= 100,000/μL. Patients with ANC \<1500/μL or plt \<100,000/μL with splenomegaly or extensive bone marrow involvement as the etiology for their cytopenias are eligible.
- creatinine clearance of \>60 mL/min as determined by the Cockcroft-Gault calculation.
- Total bilirubin \<= 2X upper limit laboratory normal (ULN). Patients with non-clinically significant elevations of bilirubin due to Gilbert's disease are not required to meet these criteria.
- Serum transaminases AST (SGOT) and ALT (SGPT) \<=5x ULN, Serum alkaline phosphatase ≤5 X ULN.
- Disease free of prior malignancies for ≥ 2 years with the exception of basal or squamous cell skin carcinoma, carcinoma "in situ" of the breast or cervix, or localized prostate cancer (treated definitively with hormone therapy, radiotherapy, or surgery).
- Patients may have received prior therapy with bendamustine or lenalidomide, but must not have disease that is refractory to bendamustine or lenalidomide.
- Prior therapy with rituximab is permitted, even in the setting of rituximab refractory disease.
You may not qualify if:
- Has received \>5 lines of prior therapy for their disease. Re-treatment with an identical regimen does not count as a new regimen.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form or comply with the protocol treatment.
- Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking lenalidomide.
- Prior history or current evidence of central nervous system or leptomeningeal involvement.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Known to be positive for HIV or infectious hepatitis, type B or C.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- Celgene Corporationcollaborator
Study Sites (10)
St Vincent Regional Cancer Center
Green Bay, Wisconsin, 54301, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, 54313, United States
Mercy Health System Heme/Onc
Janesville, Wisconsin, 53548, United States
Gundersen Clinic
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Riverview Hospital
Wisconsin Rapids, Wisconsin, 54494, United States
Related Publications (1)
Chang JE, Wang T, Kim K, Folstad M, Endres M, Howard M, Kenkre V, Fletcher C, Rajguru S. Maintenance low-dose fixed duration lenalidomide and rituximab following bendamustine and rituximab induction in previously untreated chronic lymphocytic leukemia and small lymphocytic lymphoma. Leuk Lymphoma. 2024 Oct;65(10):1456-1464. doi: 10.1080/10428194.2024.2360535. Epub 2024 Jun 10.
PMID: 38856101DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Julie E. Chang, MD
- Organization
- University of Wisconsin
Study Officials
- PRINCIPAL INVESTIGATOR
Julie Chang, MD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2009
First Posted
September 10, 2009
Study Start
October 1, 2009
Primary Completion
July 1, 2013
Study Completion
April 1, 2015
Last Updated
December 2, 2019
Results First Posted
July 13, 2017
Record last verified: 2017-07