Lenalidomide, Rituximab, Cyclophosphamide, and Dexamethasone in Treating Patients With Previously Untreated Low-Grade Non-Hodgkin Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage I grade 1 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, stage III grade 1 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, stage III grade 2 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage I small lymphocytic lymphoma, contiguous stage II small lymphocytic lymphoma, noncontiguous stage II small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, Waldenstrom macroglobulinemia, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, stage I marginal zone lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II marginal zone lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed symptomatic non-Hodgkin lymphoma by biopsy within the past 6 months
Any of the following subtypes allowed:
- Grade 1 or 2 lymphoma
- Small lymphocytic lymphoma
- Marginal zone lymphoma
- Lymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia [WM])
- Previously untreated disease that, in the investigator's opinion, requires treatment
Measurable disease by CT or MRI scans with lymph nodes ≥ 2.0 cm in ≥ 1 dimension
WM patients without lymphadenopathy must meet the following criteria:
- More than 10% lymphocytes, lymphoplasmacytic cells, or plasma cells on a bone marrow aspirate/biopsy
- Quantitative Immunoglobulin M ≥ 400 mg/dL NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,400/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 2.0 mg/dL
- Total or direct bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception at least 28 days prior to, during, and for 28 days after completion of study therapy
- Able to take acetylsalicylic acid (ASA) 325 mg/day as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin)
- No known hypersensitivity to thalidomide
- No development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would limit compliance with study requirements
- No myocardial infarction within the past 6 months
- No other active malignancy requiring treatment, except for localized nonmelanomatous skin cancer or any cancer that, in the judgement of the investigator, has been treated with curative intent and will not interfere with the study treatment plan and response assessment
- No co-morbid systemic illnesses or other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into the study or would interfere significantly with the proper assessment of safety and toxicity of study treatment
- No known positivity for HIV or infectious hepatitis A, B, or C
- No serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent
- Willing to return to Mayo Clinic enrolling institution for follow up
- Registered into the RevAssist® program and willing and able to comply with the requirements of RevAssist®
PRIOR CONCURRENT THERAPY:
- No prior lenalidomide
- No prior irradiation to ≥ 25% of the bone marrow
- More than 28 days since prior experimental drug or therapy
- No concurrent radiotherapy, chemotherapy, or immunotherapy
- No other concurrent anticancer agents or treatments, including thalidomide or investigational agents
Sites / Locations
- Mayo Clinic in Arizona
- Mayo Clinic
Arms of the Study
Arm 1
Experimental
Treatment
Participants with symptomatic untreated low grade NHL will be treated according to a 28 day schedule for up to a maximum of 12 consecutive cycles: 375 mg/m^2 Rituximab IV on day 1. 20 mg Lenalidomide taken orally on days 1-21. 250 mg/m^2 Cyclophosphamide orally on days 1, 8, 15. 40 mg Dexamethasone orally on days 1, 8, 15, 22.