Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma

Completed · Phase 2

Conditions studied: Ann Arbor Stage II Grade 1 Contiguous Follicular Lymphoma, Ann Arbor Stage II Grade 1 Non-Contiguous Follicular Lymphoma, Ann Arbor Stage II Grade 2 Contiguous Follicular Lymphoma, Ann Arbor Stage II Grade 2 Non-Contiguous Follicular Lymphoma, Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma, Ann Arbor Stage II Grade 3 Non-Contiguous Follicular Lymphoma, Ann Arbor Stage III Grade 1 Follicular Lymphoma, Ann Arbor Stage III Grade 2 Follicular Lymphoma, Ann Arbor Stage III Grade 3 Follicular Lymphoma, Ann Arbor Stage IV Grade 1 Follicular Lymphoma, Ann Arbor Stage IV Grade 2 Follicular Lymphoma, Ann Arbor Stage IV Grade 3 Follicular Lymphoma

In brief

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.

Key facts

Study ID: NCT01145495
Run by: National Cancer Institute (NCI)
People needed: 66
Starts: 2010-06-15
Expected to finish: 2022-01-15
Last updated by the study team: 2023-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)
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

Where it is running

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
Palo Alto Medical Foundation-Camino Division — Mountain View, California, United States

Full record on ClinicalTrials.gov

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