Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
NCT ID: NCT01145495
Last Updated: 2023-06-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2010-06-15
2022-01-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Rituximab, Lenalidomide, and Ibrutinib in Treating Patients With Previously Untreated Stage II-IV Follicular Lymphoma
NCT01829568
Lenalidomide in Combination With Rituximab in Treating Participants With Stage III/IV Indolent Non-Hodgkin Lymphoma
NCT00695786
Rituximab and/or Lenalidomide in Treating Patients With Follicular Non-Hodgkin's Lymphoma That is Not Refractory to Rituximab
NCT00238238
Rituximab in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma
NCT00112931
Lenalidomide And Rituximab as Maintenance Therapy in Treating Patients With B-Cell Non-Hodgkin Lymphoma
NCT01045928
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To determine the response rate (overall and complete) to lenalidomide + rituximab in follicular non-Hodgkin lymphoma (NHL) patients who have received no prior systemic therapy.
II. To determine the time to progression after lenalidomide + rituximab in previously untreated patients with cluster of differentiation (CD)20+ follicular NHL.
SECONDARY OBJECTIVES:
I. To determine the toxicity profile of lenalidomide + rituximab therapy in previously untreated patients with CD20+ follicular NHL.
II. To establish whether the therapeutic effects of lenalidomide + rituximab combination are sufficiently promising to warrant evaluation in a subsequent randomized trial (in comparison to rituximab alone).
III. To correlate fragment crystallizable gamma (Fcg) receptor polymorphism profiling with response to lenalidomide + rituximab in previously untreated patients with follicular NHL.
IV. To determine the impact of lenalidomide on immune parameters in patients with previously untreated follicular lymphoma.
V. To determine the impact of lenalidomide on angiogenic parameters in patients with previously untreated follicular lymphoma.
VI. To correlate lymphoma-associated macrophages (LAM) and forkhead box P3 (FOXP3), granzyme B (GzB), CD10, multiple myeloma oncogene 1 (MUM1), and B-cell lymphoma 2 (BCL2) expression with response to rituximab + lenalidomide in previously untreated patients with follicular lymphoma.
VII. Determine whether immune gene signatures previously identified as prognostic factors in follicular lymphoma (FL) can be applied to paraffin-embedded tissues in rituximab treated patients; evaluate micro ribonucleic acid (RNA) signatures associated with these gene signatures and outcome; to validate immunohistochemical markers associated with outcome in FL (CD68 LAMs, FOXP3, CD10, BCL6, FOXP1, MUM1); and investigate whether markers of angiogenesis may be of value in prognosis of FL.
OUTLINE:
Patients receive lenalidomide orally (PO) once daily (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 intravenously (IV) on days 1, 8, 15, and 22 and on weeks 13, 21, 29, and 37 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 months for 2 years and then every 6 months for up to 8 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment (lenalidomide, rituximab)
Patients 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.
Laboratory Biomarker Analysis
Correlative studies
Lenalidomide
Given PO
Rituximab
Given IV
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Laboratory Biomarker Analysis
Correlative studies
Lenalidomide
Given PO
Rituximab
Given IV
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
* No known central nervous system (CNS) involvement by lymphoma
* Patients with human immunodeficiency virus (HIV) infection are eligible, provided they meet the following
* No evidence of coinfection with hepatitis B or C
* CD4+ cell count \>= 400/mm\^3
* No evidence of resistant strains of HIV
* If not on anti-HIV therapy, HIV viral load \< 10,000 copies HIV RNA/mL
* If on anti-HIV therapy, HIV viral load \< 50 copies HIV RNA/mL
* No history of acquired immune deficiency syndrome (AIDS)-defining conditions
* No evidence of active hepatitis B or C infection (i.e., no positive serology for anti-hepatitis B core \[HBc\] or anti-hepatitis C virus \[HCV\] antibodies); hepatitis B virus (HBV) seropositive patients (hepatitis B surface antigen positive \[HBsAg +\]) are eligible if they are closely monitored for evidence of active HBV infection by HBV deoxyribonucleic acid (DNA) testing and receive suppressive therapy with lamivudine or other HBV suppressive therapy until 6 months after the last rituximab dose
* Patients with a history of erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome are not eligible
* Patients with uncontrolled seizures are not eligible
* Patients with an autoimmune disorder requires active immunosuppression are not eligible
* Non-pregnant and non-nursing; females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to registration; further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy; a FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time preceding 24 consecutive months); all patients must be counseled by a trained counselor every 28 days about pregnancy precautions and risks of fetal exposure
* No known human anti-chimeric antibody (HACA) positivity
* Absolute neutrophil count (ANC) \>= 1,000/microliter
* Platelet count \>= 75,000/microliter
* Creatinine clearance \>= 30 mL/min unless attributable to NHL; to be calculated by method of Cockcroft-Gault, using actual weight; maximum creatinine clearance (CrCl) 125 mL/min
* Total bilirubin =\< 2 times upper limit of normal (ULN) unless attributable to NHL or Gilbert disease
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter Martin
Role: PRINCIPAL_INVESTIGATOR
Alliance for Clinical Trials in Oncology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
AdventHealth Orlando
Orlando, Florida, United States
Saint Joseph Medical Center
Bloomington, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Graham Hospital Association
Canton, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Heartland Cancer Research NCORP
Decatur, Illinois, United States
Eureka Hospital
Eureka, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Illinois CancerCare-Havana
Havana, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
AMITA Health Adventist Medical Center
La Grange, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Mcdonough District Hospital
Macomb, Illinois, United States
Holy Family Medical Center
Monmouth, Illinois, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States
Bromenn Regional Medical Center
Normal, Illinois, United States
Carle Cancer Institute Normal
Normal, Illinois, United States
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Illinois Valley Hospital
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
Eastern Maine Medical Center
Bangor, Maine, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Christiana Care - Union Hospital
Elkton, Maryland, United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States
Southeast Cancer Center
Cape Girardeau, Missouri, United States
Saint Luke's Hospital
Chesterfield, Missouri, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, United States
Capital Region Southwest Campus
Jefferson City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Center for Cancer Care and Research
St Louis, Missouri, United States
Comprehensive Cancer Care PC
St Louis, Missouri, United States
CHI Health Saint Francis
Grand Island, Nebraska, United States
Great Plains Health Callahan Cancer Center
North Platte, Nebraska, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, United States
Exeter Hospital
Exeter, New Hampshire, United States
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, United States
Solinsky Center for Cancer Care
Manchester, New Hampshire, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, United States
Glens Falls Hospital
Glens Falls, New York, United States
Northwell Health NCORP
Lake Success, New York, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
NYP/Weill Cornell Medical Center
New York, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Randolph Hospital
Asheboro, North Carolina, United States
Mission Hospital
Asheville, North Carolina, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Vidant Oncology-Kinston
Kinston, North Carolina, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States
University of Vermont and State Agricultural College
Burlington, Vermont, United States
Danville Regional Medical Center
Danville, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Lansigan 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.
Martin 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2011-02047
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000675161
Identifier Type: -
Identifier Source: secondary_id
CALGB 50803
Identifier Type: OTHER
Identifier Source: secondary_id
CALGB-50803
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-02047
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.