Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
A Phase II Trial of Bortezomib (NSC #681239) + Lenalidomide (Revlimid™, CC-5013) (NSC #703813) for Relapsed/Refractory Mantle Cell Lymphoma
6 other identifiers
interventional
53
1 country
82
Brief Summary
This phase II trial studies how well bortezomib and lenalidomide work in treating patients with mantle cell lymphoma that has come back after a period of improvement (refractory) or is not responding to treatment (refractory). Bortezomib may also stop the growth of cancer cells by blocking some proteins needed for cell growth. Lenalidomide may stimulate the immune system to kill cancer cells and may also block the growth of new blood vessels necessary for cell growth. Giving bortezomib with lenalidomide may be an effective treatment for relapsed or refractory mantle cell lymphoma.
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 Nov 2007
Longer than P75 for phase_2
82 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
November 2, 2007
CompletedFirst Posted
Study publicly available on registry
November 5, 2007
CompletedStudy Start
First participant enrolled
November 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2014
CompletedResults Posted
Study results publicly available
February 20, 2014
CompletedOctober 30, 2018
October 1, 2018
5.1 years
November 2, 2007
January 6, 2014
October 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With an Overall Response Defined as Complete Response and Partial Response
Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a \>/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.
Duration of treatment (assessed up to 6 years)
Secondary Outcomes (3)
Incidence of Adverse Events
Duration of Treatment (up to 6 years)
Time to Progression
Assessed up to 6 years
Overall Survival
Assessed up to 6 years
Study Arms (1)
Treatment (bortezomib, lenalidomide)
EXPERIMENTALPatients receive induction therapy comprising bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide PO QD on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib IV on days 1 and 8 and lenalidomide PO QD on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given PO
Eligibility Criteria
You may qualify if:
- Histologically documented mantle cell lymphoma, with the following immunophenotypic characteristics: cluster of differentiation (CD)5+, CD23-, cyclin D1+; this may be from an initial diagnostic biopsy, or one obtained at time of relapse
- Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine needle aspirates are not acceptable
- Failure to submit pathology specimens within 60 days of patient registration will be considered a major protocol violation
- Institutional flow cytometry or immunohistochemistry must confirm CD5 antigen expression, lack of CD23 antigen expression, and expression of cyclin D1
- Prior therapy with at least one regimen, which may have been single agent or multi-agent, and consisted of traditional cytotoxic agents and/or biologic agents; patient may not have received prior bortezomib or lenalidomide therapy; patient must have progressive disease or refractory disease following that initial regimen(s); refractory disease will be defined as stable disease (SD) or progressive disease (PD) as best response to prior therapy, or CR or PR as initial response followed by disease progression within 6 months
- Prior autologous, but not allogeneic, stem cell transplant is allowed
- No corticosteroids within two weeks prior to study, except for maintenance therapy for a non-malignant disease; maintenance therapy dose may not exceed 20 mg/day prednisone or equivalent
- No prior radioimmunotherapy within 12 months of study entry
- No \>= grade 3 peripheral neuropathy within a month prior to study entry
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass \> 1 cm by physical exam, computed tomography (CT), magnetic resonance imaging (MRI), or conventional radiograph is acceptable; lesions that are considered non-measurable include the following:
- Bone lesions (lesions, if present, should be noted)
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis or pulmonis
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
Kaiser Permanente-Anaheim
Anaheim, California, 92806, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California, 91706, United States
Kaiser Permanente-Bellflower
Bellflower, California, 90706, United States
Kaiser Permanente-Fontana
Fontana, California, 92335, United States
Kaiser Permanente - Harbor City
Harbor City, California, 90710, United States
Kaiser Permanente-Irvine
Irvine, California, 92618, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Kaiser Permanente-Cadillac
Los Angeles, California, 90034, United States
Kaiser Permanente - Panorama City
Panorama City, California, 91402, United States
Kaiser Permanente-Riverside
Riverside, California, 92505, United States
Kaiser Permanente-San Diego Mission
San Diego, California, 92108, United States
Kaiser Permanente-San Diego Zion
San Diego, California, 92120, United States
Kaiser Permanente-San Marcos
San Marcos, California, 92078, United States
Kaiser Permanente-Woodland Hills
Woodland Hills, California, 91367, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Graham Hospital Association
Canton, Illinois, 61520, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Heartland Cancer Research NCORP
Decatur, Illinois, 62526, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hopedale Medical Complex - Hospital
Hopedale, Illinois, 61747, United States
Mcdonough District Hospital
Macomb, Illinois, 61455, United States
Bromenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center Foundation
Normal, Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
Pekin Hospital
Pekin, Illinois, 61554, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
Illinois Valley Hospital
Peru, Illinois, 61354, United States
Valley Radiation Oncology
Peru, Illinois, 61354, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Saint Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Newton-Wellesley Hospital
Newton, Massachusetts, 02462, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, 49503, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Mercy Health Mercy Campus
Muskegon, Michigan, 49444, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Minneapolis Veterans Medical Center
Minneapolis, Minnesota, 55417, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Veterans Administration
Columbia, Missouri, 65201, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Mission Hospital Inc-Memorial Campus
Asheville, North Carolina, 28801, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Vidant Oncology-Kinston
Kinston, North Carolina, 28501, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
McLeod Regional Medical Center
Florence, South Carolina, 29506, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont College of Medicine
Burlington, Vermont, 05405, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Sovah Health Martinsville
Martinsville, Virginia, 24115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vicki Morrison, M.D.
- Organization
- Veterans Affairs Medical Center/University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Vicki Morrison
Alliance for Clinical Trials in Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2007
First Posted
November 5, 2007
Study Start
November 15, 2007
Primary Completion
December 31, 2012
Study Completion
January 21, 2014
Last Updated
October 30, 2018
Results First Posted
February 20, 2014
Record last verified: 2018-10