Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
A Phase II Trial of Lenalidomide (Revlimid (TM), CC-5013) (NSC #703813) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)
6 other identifiers
interventional
66
1 country
91
Brief Summary
This phase II trial studies how well lenalidomide and rituximab work in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide together with rituximab may kill more cancer cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2010
Longer than P75 for phase_2
91 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
June 15, 2010
CompletedStudy Start
First participant enrolled
June 15, 2010
CompletedFirst Posted
Study publicly available on registry
June 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2012
CompletedResults Posted
Study results publicly available
February 20, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2022
CompletedJune 27, 2023
June 1, 2023
2.5 years
June 15, 2010
January 6, 2014
June 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Achieved a Complete Response
Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.
At 12 months
Secondary Outcomes (3)
Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Up to 5 years
Disease Progression
Up to 5 years
Best Response
Up to 5 years
Study Arms (1)
Treatment (lenalidomide, rituximab)
EXPERIMENTALPatients receive lenalidomide PO QD on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, 15, and 22 and in weeks 13, 21, 29, and 37 in the absence of disease progression or unacceptable toxicity.
Interventions
Given PO
Given IV
Eligibility Criteria
You may qualify if:
- Previously untreated, histologically confirmed follicular lymphoma, World Health Organization (WHO) classification grade 1, 2, or 3a (\> 15 centroblasts per high power field with centrocytes present) that is stage III, IV, or bulky (i.e., single mass \>= 7 cm in any uni-dimensional measurement) stage II
- 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 for diagnosis
- 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 CD20 antigen expression
- Low or intermediate risk by Follicular Lymphoma International Prognostic Index (FLIPI): 0-2 risk factors
- No prior systemic therapy for NHL, including chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy); patients may have received involved-field radiation therapy
- No corticosteroids within two weeks prior to study entry, except for maintenance therapy for a non-malignant disease
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 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 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/pulmonis
- Bone marrow (involvement by NHL should be noted)
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (91)
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301, 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
AdventHealth Orlando
Orlando, Florida, 32803, United States
Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Graham Hospital Association
Canton, Illinois, 61520, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
University of Illinois
Chicago, Illinois, 60612, 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
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Havana
Havana, Illinois, 62644, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
AMITA Health Adventist Medical Center
La Grange, Illinois, 60525, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Mcdonough District Hospital
Macomb, Illinois, 61455, United States
Holy Family Medical Center
Monmouth, Illinois, 61462, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, 61462, United States
Bromenn Regional Medical Center
Normal, Illinois, 61761, United States
Carle Cancer Institute Normal
Normal, Illinois, 61761, United States
Illinois CancerCare-Community Cancer Center
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
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
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
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois Valley Hospital
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Illinois CancerCare-Spring Valley
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
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600, United States
Christiana Care - Union Hospital
Elkton, Maryland, 21921, United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
Saint Luke's Hospital
Chesterfield, Missouri, 63017, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212, United States
Capital Region Southwest Campus
Jefferson City, Missouri, 65109, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Center for Cancer Care and Research
St Louis, Missouri, 63141, United States
Comprehensive Cancer Care PC
St Louis, Missouri, 63141, United States
CHI Health Saint Francis
Grand Island, Nebraska, 68803, United States
Great Plains Health Callahan Cancer Center
North Platte, Nebraska, 69101, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301, United States
Exeter Hospital
Exeter, New Hampshire, 03833, United States
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, 03246, United States
Solinsky Center for Cancer Care
Manchester, New Hampshire, 03103, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
Northwell Health NCORP
Lake Success, New York, 11042, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Randolph Hospital
Asheboro, North Carolina, 27203, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Vidant Oncology-Kinston
Kinston, North Carolina, 28501, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, 27320, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, 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 and State Agricultural College
Burlington, Vermont, 05405, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Related Publications (3)
Rutherford SC, Yin J, Pederson L, Perez Burbano G, LaPlant B, Shadman M, Li H, LeBlanc ML, Kenkre VP, Hong F, Blum KA, Dockter T, Martin P, Jung SH, Grant B, Rosenbaum C, Ujjani C, Barr PM, Unger JM, Cheson BD, Bartlett NL, Kahl B, Friedberg JW, Mandrekar SJ, Leonard JP. Relevance of Bone Marrow Biopsies for Response Assessment in US National Cancer Institute National Clinical Trials Network Follicular Lymphoma Clinical Trials. J Clin Oncol. 2023 Jan 10;41(2):336-342. doi: 10.1200/JCO.21.02301. Epub 2022 Jul 5.
PMID: 35787017DERIVEDLansigan F, Barak I, Pitcher B, Jung SH, Cheson BD, Czuczman M, Martin P, Hsi E, Schoder H, Smith S, Bartlett NL, Leonard JP, Blum KA. The prognostic significance of PFS24 in follicular lymphoma following firstline immunotherapy: A combined analysis of 3 CALGB trials. Cancer Med. 2019 Jan;8(1):165-173. doi: 10.1002/cam4.1918. Epub 2018 Dec 21.
PMID: 30575311DERIVEDMartin P, Jung SH, Pitcher B, Bartlett NL, Blum KA, Shea T, Hsi ED, Ruan J, Smith SE, Leonard JP, Cheson BD. A phase II trial of lenalidomide plus rituximab in previously untreated follicular non-Hodgkin's lymphoma (NHL): CALGB 50803 (Alliance). Ann Oncol. 2017 Nov 1;28(11):2806-2812. doi: 10.1093/annonc/mdx496.
PMID: 28945884DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Martin, M.D.
- Organization
- Weill Cornell Medical College
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Martin
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
June 15, 2010
First Posted
June 16, 2010
Study Start
June 15, 2010
Primary Completion
December 31, 2012
Study Completion
January 15, 2022
Last Updated
June 27, 2023
Results First Posted
February 20, 2014
Record last verified: 2023-06