Clinical trial NCT01419795 (phase 2, status: terminated)
Conditions: adult nasal type extranodal nk/t-cell lymphoma, anaplastic large cell lymphoma, angioimmunoblastic t-cell lymphoma, cutaneous b-cell non-hodgkin lymphoma, extranodal marginal zone b-cell lymphoma of mucosa-associated lymphoid tissue, hepatosplenic t-cell lymphoma, intraocular lymphoma, nodal marginal zone b-cell lymphoma, noncutaneous extranodal lymphoma, peripheral t-cell lymphoma, prolymphocytic leukemia, 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 adult t-cell leukemia/lymphoma, recurrent cutaneous t-cell non-hodgkin 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 mycosis fungoides/sezary syndrome, recurrent small lymphocytic lymphoma, refractory chronic lymphocytic leukemia, refractory hairy cell leukemia, small intestine lymphoma, splenic marginal zone lymphoma, t-cell large granular lymphocyte leukemia, testicular lymphoma, waldenström 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, C91.31, C91.32, C91.61, C91.62, C91.30, C91.60, 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, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, A87.2, K52.832, D72.111, C91.11, C91.12, C91.10, D46.4, D46.1, D46.A, D46.0, D46.20, D46.21, D46.22, 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, C81.37, C81.47, C81.07, C81.30, C81.40, C81.00, C81.32, 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: 
    low accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Understand and voluntarily sign an informed consent form

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

          -  Patients with CLL/SLL/PLL or NHL and who:

               -  Met the criteria of relapse or progression after allogeneic HCT according to the
                  HCT protocol or the attending discretion and who,

               -  Not responding to appropriate tapering of immunosuppressive medications

          -  Absolute neutrophil count (ANC) >= 1500/mm^3 or >= 1000/mm^3 if ANC has persistently <
             1500/ mm^3 for more than 2 weeks

          -  Platelet count (transfusion independent) >= 50,000/mm^3 or >= 20,000/mm^3 if platelet
             count has persistently < 50,000/mm^3 for more than 2 weeks

          -  Creatinine clearance >= 30ml/min by Cockcroft-Gault formula

          -  Total bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN if total bilirubin
             has been persistently > 1.5 x ULN for more than 2 weeks

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and
             alanine transaminase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x ULN or
             =< 5 x ULN if AST or ALT have been persistently > 3 x ULN for more than 2 weeks

          -  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) 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

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

          -  Study participants with risk factors for venous thrombo-embolism (VTE), such as
             previous VTE, cardiac disease, chronic renal insufficiency, and/or poorly controlled
             diabetes, should be able to comply with some degree of prophylactic anticoagulation
             using aspirin 81 or 325 mg daily, coumadin, or low molecular weight heparin

        Exclusion Criteria:

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the patient from signing the informed consent form

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

          -  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

          -  Known hypersensitivity to thalidomide

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

          -  Resistance to prior use of lenalidomide, defined as progression on full dose
             lenalidomide within the first two cycles of therapy

          -  Concurrent use of other anti-cancer agents or treatments

          -  Known seropositive for or active viral infection with human immunodeficiency virus

          -  Karnofsky performance status < 50%

          -  Active grades III or IV acute graft-versus-host disease (GVHD)