Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full Description

PRIMARY OBJECTIVES:

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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
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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

63

Study ID:

NCT01145495

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 77 Locations for this study

See Locations Near You

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 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, 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
Saint Louis Missouri, 63110, United States
Missouri Baptist Medical Center
Saint Louis Missouri, 63131, United States
Center for Cancer Care and Research
Saint Louis Missouri, 63141, United States
Comprehensive Cancer Care PC
Saint 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 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

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

63

Study ID:

NCT01145495

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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