A Study of Lenalidomide Combined with a Standard Chemotherapy for Treating Patients with Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma


About this study

The purpose of this study is to assess the safety, effectiveness and strongest tolerated dose of lenalidomide when given together with a standard chemotherapy to treat patients who have newly diagnosed stage II-IV peripheral T-cell non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stop the growth of peripheral T-cell non-Hodgkin's lymphoma by blocking the growth of new blood vessels necessary for cancer growth. Giving combination chemotherapy with lenalidomide may be a better treatment for peripheral T-cell non-Hodgkin's lymphoma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Histologically confirmed new diagnosis of
    • Stage II, III and IV peripheral T-cell non-Hodgkin's lymphoma not otherwise specified 
    • Anaplastic large cell lymphoma ALK negative or 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 should be sent for retrospective diagnostic review, and the diagnosis confirmed by Mayo Clinic
    • Hematoxylin and eosin (H&E) stain
    • Immunohistochemistry (IHC) slides 
    • A representative formalin-fixed paraffin-embedded (FFPE) tissue block
    • The pathology report from initial diagnosis 
    • 8 unstained slides of 4 micron thickness to store for future IHC and deoxyribonucleic acid [DNA]
      • Treatment may commence prior to the Mayo Clinic retrospective diagnostic review
      • The diagnostic H&E slide and IHC slides will be returned after review
      • Only the 8 unstained slides will be retained/stored for future use
  • No prior therapy with the exception of prior radiation therapy and/or 1 cycle of any chemotherapy regimen or prednisone alone based on current diagnosis and clinical condition
    • This cycle of 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 cytopenic due to non-Hodgkin lymphoma bone marrow involvement or splenomegaly
  • Platelet count > 100 mm^3 
    • > 75 mm^3 if bone marrow involvement or splenomegaly
  • Total bilirubin ≤ 1.5 x upper normal limit
    • ≤ 3 x upper normal limit if documented hepatic involvement with lymphoma
    • ≤ 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 
  • Calculated creatinine clearance (CrCl) > 45 mL/min (Cockcroft-Gault)
  • Prothrombin time (PT), 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 must be willing and able to take aspirin (81 or 325 mg) daily
    • If aspirin is contraindicated, may be considered for the study if on therapeutic dose warfarin or low molecular weight heparin
    • If unable to take any prophylaxis is not eligible
  • Has measurable disease
    • 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) scans will not constitute evaluable disease unless verified by computed tomography (CT) scan or other appropriate imaging
    • 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 a CT scan will constitute measurable disease 
    • Skin lesions can be used as measurable disease provided bi-dimensional measurements are possible
  • Proof of lymphoma in the liver requires a confirmation biopsy 
  • All 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
    • 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
    • If of reproductive potential must agree to follow accepted birth control measures
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Must be willing to give written informed consent and sign an institutionally approved consent form before the performance of any study-related procedure not part of normal medical care except for 1 cycle of chemotherapy based on current diagnosis and clinical condition
    • Consent may be withdrawn by the subject at any time without prejudice to future medical care
  • Has no serious disease or condition that, in the opinion of the investigator, would compromise ability to participate in the study

Exclusion Criteria

  • Pregnant or breast feeding
  • Known to be seropositive for or has an active viral infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
    • If seropositive because of hepatitis B virus vaccine, then still eligible
  • Major surgery within 2 weeks of study drug administration
  • Prior malignancies within the past 3 years with exception of
    • Adequately treated basal cell or squamous cell skin cancer
    • 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
  • A diagnosis of other peripheral T-cell lymphoma 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)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Stephen Ansell, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


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