Clinical trial NCT02561273 (phase 1/phase 2, status: active, not recruiting)
Conditions: anaplastic large cell lymphoma, alk-negative, anaplastic large cell lymphoma, alk-positive, hepatosplenic t-cell lymphoma, peripheral t-cell lymphoma, not otherwise specified, stage ii angioimmunoblastic t-cell lymphoma, stage ii enteropathy-associated t-cell lymphoma, stage iii angioimmunoblastic t-cell lymphoma, stage iii enteropathy-associated t-cell lymphoma, stage iv angioimmunoblastic t-cell lymphoma, stage iv enteropathy-associated t-cell lymphoma
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
Drugs: cyclophosphamide, doxorubicin hydrochloride, etoposide, lenalidomide, prednisone, vincristine sulfate
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed new diagnosis of stage II, III and IV peripheral T-cell
             non-Hodgkin's lymphoma not otherwise specified (NOS), anaplastic large cell lymphoma
             (ALK negative) (ALK positive if IPI 3, 4, or 5), angioimmunoblastic T-cell lymphoma,
             enteropathy associated T-cell lymphoma, hepatosplenic gamma delta T-cell lymphoma

          -  Pathology material: hematoxylin and eosin (H&E) stain and immunohistochemistry (IHC)
             slides or a representative formalin-fixed paraffin-embedded (FFPE) tissue block along
             with the pathology report from initial diagnosis, should be sent to be reviewed, and
             the diagnosis confirmed by Mayo Clinic department (retrospective diagnostic review:
             treatment may commence prior to the Mayo Clinic review)

          -  No prior therapy with the exception of prior radiation therapy and/or prednisone
             alone, at the discretion of the investigator based on current diagnosis and clinical
             condition; this prednisone treatment will not count toward the 6 cycles of treatment
             given in the study

          -  Expected survival duration of > 3 months

          -  Karnofsky performance status > 70

          -  Absolute neutrophil count (ANC) > 1000 cells/mm^3, unless cytopenias due to
             non-Hodgkin lymphoma (NHL) (i.e., bone marrow involvement or splenomegaly)

          -  Platelet count > 100,000/uL or > 75,000/uL if bone marrow (BM) involvement or
             splenomegaly

          -  Total bilirubin =< 1.5 x upper normal limit, or =< 3 x upper normal limit if
             documented hepatic involvement with lymphoma, or =< 5 x upper normal limit if history
             of Gilbert's disease

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper
             normal limit (=< 5 x upper normal limit if documented hepatic involvement with
             lymphoma)

          -  Serum creatinine < 2.0 mg/dL or calculated creatinine clearance (CrCl) > 45 mL/min
             (Cockcroft-Gault)

          -  Prothrombin time (PT) or international normalized ratio (INR), and partial
             thromboplastin time (PTT) =< 1.5 x upper limit of normal unless patient is receiving
             anticoagulants; if patient is on warfarin therapy, levels should be within therapeutic
             range

          -  If currently not on anticoagulation medication, willing and able to take aspirin (81
             or 325 mg) daily; if aspirin is contraindicated, the patient may be considered for the
             study if on therapeutic dose warfarin or low molecular weight heparin; patients unable
             to take any prophylaxis are not eligible

          -  Patients with measurable disease; patients with non-measurable but evaluable disease
             may be eligible after discussion with the principal investigator (PI); baseline
             measurements and evaluations must be obtained within 6 weeks of registration to the
             study; abnormal positron emission tomography (PET)/computed tomography (CT) scans will
             not constitute evaluable disease, unless verified by CT scan or other appropriate
             imaging

          -  Patients with measurable disease must have at least one objective measurable disease
             parameter; a clearly defined, bi-dimensionally measurable defect or mass measuring at
             least 1.5 cm in diameter on the CT portion of a PET/CT or CT scan or magnetic
             resonance imaging (MRI) (if appropriate) will constitute measurable disease; proof of
             lymphoma in the liver is required by a confirmation biopsy; skin lesions can be used
             as measurable disease provided bi-dimensional measurements are possible

          -  All study participants must be registered into the mandatory Revlimid Risk Evaluation
             and Mitigation Strategy (REMS) program, and be willing and able to comply with the
             requirements of the REMS program

          -  Women must not be pregnant or breast-feeding

               -  Females of reproductive potential must adhere to the scheduled pregnancy testing
                  as required in the Revlimid REMS program

               -  All females of childbearing potential must have a blood test within 2 weeks prior
                  to registration to rule out pregnancy

               -  Pregnancy testing is not required for post-menopausal or surgically sterilized
                  women

          -  Male and female patients of reproductive potential must agree follow accepted birth
             control measures

          -  Patient must be able to adhere to the study visit schedule and other protocol
             requirements

          -  Patients must be willing to give written informed consent, and sign an institutionally
             approved consent form before performance of any study-related procedure not part of
             normal medical care as noted above; with the exception of 1 cycle of chemotherapy
             based on current diagnosis and clinical condition, with the understanding that consent
             may be withdrawn by the subject at any time without prejudice to future medical care

          -  No serious disease or condition that, in the opinion of the investigator, would
             compromise the patient's ability to participate in the study

        Exclusion Criteria:

          -  Pregnant or breast feeding females

          -  Known seropositive for or active viral infection with human immunodeficiency virus
             (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are
             seropositive ( i.e. hepatitis B core antibody positive; quantitative deoxyribonucleic
             acid [DNA] negative) are eligible with appropriate prophylaxis

          -  Major surgery within 2 weeks of study drug administration

          -  Prior malignancies within the past 3 years with exception of adequately treated basal
             cell, squamous cell skin cancer, or thyroid cancer; carcinoma in situ of the cervix or
             breast; prostate cancer of Gleason grade 6 or less with stable prostate-specific
             antigen (PSA) levels

          -  Patients with a diagnosis of other peripheral T-cell lymphoma (PTCL) histologies other
             than those specified in the inclusion criteria

          -  Contraindication to any of the required concomitant drugs or supportive treatments,
             including hypersensitivity to all anticoagulation and antiplatelet options, or
             antiviral drugs

          -  Any other clinically significant medical disease or condition laboratory abnormality
             or psychiatric illness that, in the Investigator's opinion, may interfere with
             protocol adherence or a subject's ability to give informed consent

          -  Known hypersensitivity to thalidomide or lenalidomide

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

          -  Ejection fraction of < 45% by either multi gated acquisition scan (MUGA) or
             echocardiogram (ECHO)