Clinical trial NCT01045928 (phase 1, status: terminated)
Conditions: adult non-hodgkin lymphoma, adult grade iii lymphomatoid granulomatosis, contiguous stage ii adult burkitt lymphoma, contiguous stage ii adult diffuse large cell lymphoma, contiguous stage ii adult diffuse mixed cell lymphoma, contiguous stage ii adult diffuse small cleaved cell lymphoma, contiguous stage ii adult immunoblastic large cell lymphoma, contiguous stage ii adult lymphoblastic lymphoma, contiguous stage ii grade 1 follicular lymphoma, contiguous stage ii grade 2 follicular lymphoma, contiguous stage ii grade 3 follicular lymphoma, contiguous stage ii mantle cell lymphoma, contiguous stage ii marginal zone lymphoma, contiguous stage ii small lymphocytic lymphoma, cutaneous b-cell non-hodgkin lymphoma, extranodal marginal zone b-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone b-cell lymphoma, noncontiguous stage ii adult burkitt lymphoma, noncontiguous stage ii adult diffuse large cell lymphoma, noncontiguous stage ii adult diffuse mixed cell lymphoma, noncontiguous stage ii adult diffuse small cleaved cell lymphoma, noncontiguous stage ii adult immunoblastic large cell lymphoma, noncontiguous stage ii adult lymphoblastic lymphoma, noncontiguous stage ii grade 1 follicular lymphoma, noncontiguous stage ii grade 2 follicular lymphoma, noncontiguous stage ii grade 3 follicular lymphoma, noncontiguous stage ii mantle cell lymphoma, noncontiguous stage ii marginal zone lymphoma, noncontiguous stage ii small lymphocytic lymphoma, recurrent adult burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult grade iii lymphomatoid granulomatosis, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, splenic marginal zone lymphoma, stage i adult burkitt lymphoma, stage i adult diffuse large cell lymphoma, stage i adult diffuse mixed cell lymphoma, stage i adult diffuse small cleaved cell lymphoma, stage i adult immunoblastic large cell lymphoma, stage i adult lymphoblastic lymphoma, stage i grade 1 follicular lymphoma, stage i grade 2 follicular lymphoma, stage i grade 3 follicular lymphoma, stage i mantle cell lymphoma, stage i marginal zone lymphoma, stage i small lymphocytic lymphoma, stage iii adult burkitt lymphoma, stage iii adult diffuse large cell lymphoma, stage iii adult diffuse mixed cell lymphoma, stage iii adult diffuse small cleaved cell lymphoma, stage iii adult immunoblastic large cell lymphoma, stage iii adult lymphoblastic lymphoma, stage iii grade 1 follicular lymphoma, stage iii grade 2 follicular lymphoma, stage iii grade 3 follicular lymphoma, stage iii mantle cell lymphoma, stage iii marginal zone lymphoma, stage iii small lymphocytic lymphoma, stage iv adult burkitt lymphoma, stage iv adult diffuse large cell lymphoma, stage iv adult diffuse mixed cell lymphoma, stage iv adult diffuse small cleaved cell lymphoma, stage iv adult immunoblastic large cell lymphoma, stage iv adult lymphoblastic lymphoma, stage iv grade 1 follicular lymphoma, stage iv grade 2 follicular lymphoma, stage iv grade 3 follicular lymphoma, stage iv mantle cell lymphoma, stage iv marginal zone lymphoma, stage iv small lymphocytic lymphoma, waldenstrom macroglobulinemia
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, 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S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C88.0
Drugs: lenalidomide
SMILES: NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O
Reason stopped: 
    extreme toxicity in phase i, study did not proceed to phase ii
  
Eligibility criteria:

        Inclusion Criteria:

          -  Understand and voluntarily sign an informed consent form

          -  Able to adhere to the study visit schedule and other protocol requirements

          -  Histologic diagnosis of CD20+ B-cell NHL including diffuse large B-cell lymphoma,
             follicular lymphoma, mantle cell lymphoma and other B-cell lymphomas excluding chronic
             lymphocytic leukemia

          -  Received high-dose chemotherapy with autologous stem cell transplantation (ASCT) from
             42 to 128 days before enrollment with stable disease, partial response or complete
             response following ASCT

          -  All previous cancer therapy, including radiation, hormonal therapy and surgery, must
             have been discontinued at least 4 weeks prior to treatment in this study

          -  ECOG performance status of =< 2 at study entry; Karnofsky performance status of >= 70%
             at study entry

          -  Absolute neutrophil count >= 1,500/mm^3

          -  Platelet count >= 75,000/mm^3

          -  Serum creatinine =< 2.0 mg/dL

          -  Phase I subjects must have estimated or measured creatinine clearance >= 60 ml/min

          -  Phase II subjects must have estimated or measured creatinine clearance >= 30 ml/min

          -  Total bilirubin =< 1.5 mg/dL

          -  AST (SGOT) and ALT (SGPT) =< 2 x ULN or =< 5 x ULN if hepatic metastases are present

          -  Disease free of prior malignancies for >= 5 years with exception of currently treated
             basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix
             or breast

          -  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 prior to and again
             within 24 hours of prescribing lenalidomide for cycle 1 (prescriptions must be filled
             within 7 days)

          -  Must also 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

          -  Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (subjects
             intolerant to ASA may use warfarin or low molecular weight heparin)

          -  All study participants must be registered into the mandatory RevAssist program, and be
             willing and able to comply with the requirements of RevAssist

        Exclusion Criteria:

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that in
             the opinion of the investigator would prevent the subject from providing written
             informed consent

          -  Pregnant or breast feeding females (lactating females must agree not to breast feed
             while taking lenalidomide)

          -  Use of any other experimental drug or therapy within 28 days of baseline

          -  Known hypersensitivity to thalidomide

          -  The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs

          -  Known hypersensitivity to rituximab

          -  Concurrent use of other anti-cancer agents or treatments

          -  Known positive for HIV or infectious hepatitis, type B or C

          -  Residual grade 3 or grade 4 non-hematologic toxicity after ASCT

          -  Transfusion requirement (red blood cells or platelets) within 14 days prior to
             baseline

          -  Use of hematopoietic growth factor (including filgrastim, pegfilgrastim, sargramostim,
             erythropoietin, or darbepoetin) within 14 days prior to baseline

          -  Any other condition not defined above, including the presence of laboratory
             abnormalities, which in the opinion of the investigator would place the subject at
             unacceptable risk if he/she were to participate in the study, or would confound the
             ability to interpret data from the study

          -  Prior use of lenalidomide either concurrently with rituximab or within 8 weeks
             following a dose of rituximab

          -  Concomitant use of other anti-cancer therapies, including radiation, thalidomide, or
             other investigational agents is not permitted while subjects are receiving protocol
             therapy during the treatment phase of the study

          -  Corticosteroid therapy also is not permitted while subjects are receiving protocol
             therapy during the treatment phase of the study