A Study of Lenalidomide and Rituximab in the Treatment of Relapsed Mantle Cell Lymphoma and Diffuse Large B-cell Non-Hodgkin's Lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma (RV-LYM-PI-0056)
The goal of this clinical research study is to find the highest tolerable dose of the drug lenalidomide (Revlimid, lenalidomide) that can be given with Rituxan® (rituximab) in the treatment of relapsed mantle cell lymphoma. The safety and effectiveness of this combination treatment will also be studied in both mantle cell lymphoma and diffuse large B-cell non-Hodgkin's lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma).
Disease Group: Lymphoma
Treatment Agent: Lenalidomide,Rituximab
Treatment Location: Only at MD Anderson
Estimatated Length of Stay in Houston: No hospitalization is needed for protocol treatment purposes.
Return Visit: Day 1, Day 8, Day 15, and 21 after starting therapy during the 1st cycle every 2 weeks cycles 2 to 3 every 4 weeks after the third cycle of therapy until disease progression is documented or study drug is discontinued for another reason.
Home Care: Lenalidomide is in pill form and therefore could be taken orally at home.
1. To evaluate the safety of lenalidomide in combination with rituximab in patients with relapsed/refractory mantle cell lymphoma (MCL) and diffuse large B-cell non-hodgkin's lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma). 2. To evaluate the response rate of lenalidomide in combination with rituximab in patients with relapsed or refractory mantle cell lymphoma and diffuse large B-cell non-hodgkin's lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma). 3. To evaluate the survival of mantle cell lymphoma patients treated with lenalidomide and rituximab and diffuse large B-cell non-hodgkin's lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma).
IRB Review and Approval Date: AUG 17,2005
Recruitment Status: Not Accepting
Projected Accrual: N/A
1) Phase I and Phase II: Confirmed diagnosis of mantle cell lymphoma
with CD20 positivity in tissue biopsy. Patients must have previously
treated relapsed and/or refractory MCL. Or for Phase II: Confirmed
diagnsis of previously treated relapsed and/or refractory diffuse large
B-cell lymphoma, transformed large cell lymphoma, and/or Grade 3
follicular lymphoma (follicular cleaved large cell lymphoma or
follicular non-cleaved large cell lymphoma).
2) Understand and voluntarily sign an IRB-approved informed consent form.
3) Age equal to or greater than 18 years at the time of signing the informed consent.
4) Patients must have bi-dimensional measurable disease (bone marrow only involvement is acceptable).
5) Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
6) Serum bilirubin <1.5 mg/dl and serum creatinine < 2.0 mg/dl; platelet count >75,000/mm^3 and absolute neutrophil count (ANC) > 1,000/mm^3. AST (SGOT) and ALT (SGPT) < 2 x upper limit of normal or < 5 x upper limit of normal if hepatic metastases are present.
7) Disease free of prior malignancies of equal to or greater than 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma "in situ" of the cervix or breast, or other malignancies in remission (including prostate cancer patients in remission from radiation therapy, surgery or brachytherapy), not actively being treated, with a life expectancy > 3 years.
8) Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test 10-14 days prior to therapy and repeated within 24 hours of starting study drug and must either commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide.
9) Continuation from # 8 : (HIGHLY EFFECTIVE METHODS - Intrauterine device (IUD), hormonal (birth control pills, injections, implants), tubal ligation, partner's vasectomy. ADDITIONAL EFFECTIVE METHOD-latex condom, diaphragm, cervical cap) while on study drug.
10) WCBP must agree to have pregnancy tests every week for the first 4 weeks of treatment, then every 4 weeks if her menstrual cycles are regular or every 2 weeks if her cycles are irregular, while on study drug, and 4 weeks after the last dose of study drug. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
11) Patients may have 1 to 4 lines of prior therapy for MCL (projected median 2 prior lines of therapy). Patient may or may not have received an anthracycline-based chemotherapy regimen.
12) Patients must be willing to receive transfusions of blood products.
13) Past stem cell (autologous or allogenic) transplantation is acceptable.
14) Patients may have prior therapy with rituximab.
1) Any serious medical condition including but not limited to,
uncontrolled hypertension, diabetes mellitus, active/symptomatic
coronary artery disease, COPD, renal failure, active infection, active
hemorrhage, laboratory abnormality, or psychiatric illness that places
the patient at unacceptable risk and would prevent the subject from
signing the informed consent form. Patients with history of cardiac
arrythmias should have cardiac evaluation and clearance.
2) Pregnant or lactating females.
3) Use of any standard/experimental anti-lymphoma drug therapy, including steroids, within 3 weeks of initiation of the study or use of any experimental non-drug therapy (e.g., donor leukocyte/mononuclear cell infusions) within 56 days of initiation of the study drug treatment.
4) Known hypersensitivity to thalidomide or rituximab; including the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide.
5) Prior use of lenalidomide.
6) Known HIV infection. Patients with active hepatitis B infection (not including patients with prior hepatitis B vaccination; not including patients with positive serum Hepatitis B antibody). Known hepatitis C infection is allowed as long as there is no active disease and is cleared by GI consultation.
7) All patients with history of central nervous system lymphoma.
8) Patients with peripheral blood involvement with WBC > 20,000 are EXCLUDED for the Phase I component of the study.
9) Patients with >/= Grade 3 neuropathy.
10) Patients with active pulmonary embolism or deep vein thrombosis (30 days within diagnosis).
11) Patients with severe bradycardia (heart rate <40 bpm, hypotension, light-headedness, sycope).
Information and next steps
Phase I/Phase II
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