Lenalidomide With or Without Rituximab After Standard Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Lenalidomide; Lenalidomide; Rituximab
Intervention description: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.; Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles; Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization.
Intervention MeSH terms: Rituximab; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I adult diffuse large cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma

Summary:

      RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the
      cancer. It may also stimulate the immune system in different ways and stop cancer cells from
      growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways.
      Some block the ability of cancer cells to grow and spread. Others find cancer cells and help
      kill them or carry cancer-killing substances to them. It is not yet known whether
      lenalidomide is more effective with or without rituximab in treating diffuse large B-cell
      non-Hodgkin lymphoma.

      PURPOSE: This randomized phase II trial is studying lenalidomide to see how well it works
      when given with or without rituximab after standard chemotherapy in treating patients with
      diffuse large B-cell non-Hodgkin lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Understand and voluntarily sign an Informed Consent form

          2. Age > 18 years at time of signing the Informed Consent Form

          3. Able to adhere to the study visit schedule and other protocol requirements.

          4. Patients with histological confirmation of diffuse large B cell lymphoma with at least
             one of the following characteristics:

               -  High or intermediate IPI score (See Appendix 8.0 for IPI scoring criteria)

               -  Patients who are still PET scan positive mid therapy with R-CHOP, but, have
                  turned negative after completion of therapy.

               -  Low risk International prognostic index ie., an IPI score of <3 if age >60 years
                  or <2 if age is less than or equal to 60 with c-myc positive by Fluorescent In
                  situ Hybridization.

          5. No other previous lymphoma therapy, hormonal therapy or surgery, except for standard
             therapy with R-CHOP with or without radiation and with or without prophylactic
             Methotrexate therapy. Patients must be enrolled within 4-12 weeks of completion of
             therapy.

          6. At the time of study entry following standard therapy with R-CHOP±RT, patients should
             be in complete remission.

          7. ECOG performance status of ≤ 2 at study entry

          8. Laboratory test results within these ranges:

               -  Absolute neutrophil count ≥ 1500/mm³

               -  Platelet count ≥100K /mm³

               -  Serum creatinine ≤ 2.0 mg/dL

               -  Total bilirubin ≤ 1.5 mg/dL

               -  AST (SGOT) and ALT (SGPT) ≤ 2 x ULN

          9. Disease free of prior malignancies for ≥ 3 years with exception of currently treated
             basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the
             cervix or breast.

         10. All study participants must be registered into the mandatory Revlimid REMS® program,
             and be willing and able to comply with the requirements of the Revlimid REMS® program.

             •Females of childbearing potential (FCBP)† must have a negative serum or urine
             pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again
             within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be
             filled within 7 days as required by the Revlimid REMS® program) and 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 she starts taking 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.

         11. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation, if patients
             are thought to be at an elevated risk of thrombosis.

        Exclusion Criteria:

          1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the Informed Consent

          2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed
             while taking lenalidomide).

          3. Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study.

          4. Use of any other experimental drug or therapy within 28 days of baseline.

          5. Known hypersensitivity to thalidomide.

          6. The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          7. Any prior use of lenalidomide.

          8. Concurrent use of other anti-cancer agents or treatments.

          9. Known positive for HIV or infectious hepatitis, type B or C.

         10. A diagnosis of deep vein thromboses in the preceding 3 months of study enrollment.