Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL
NCT ID: NCT00974233
Last Updated: 2019-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
34 participants
INTERVENTIONAL
2009-10-31
2015-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Induction/Maintenance chemotherapy
Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
Bendamustine
90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles
Rituximab
375 mg/m2 Day 1 every 28 days for 6 cycles
Lenalidomide
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.
Interventions
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Bendamustine
90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles
Rituximab
375 mg/m2 Day 1 every 28 days for 6 cycles
Lenalidomide
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Julie Chang, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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St Vincent Regional Cancer Center
Green Bay, Wisconsin, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, United States
Mercy Health System Heme/Onc
Janesville, Wisconsin, United States
Gundersen Clinic
La Crosse, Wisconsin, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Riverview Hospital
Wisconsin Rapids, Wisconsin, United States
Countries
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References
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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.
Related Links
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University of Wisconsin Carbone Cancer Center
Other Identifiers
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RV-CLL/SLL-PI-397
Identifier Type: -
Identifier Source: secondary_id
A534260
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH\MEDICINE\HEM-ONC
Identifier Type: OTHER
Identifier Source: secondary_id
H-2009-0087
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-00646
Identifier Type: REGISTRY
Identifier Source: secondary_id
HO08405
Identifier Type: -
Identifier Source: org_study_id
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