Ensayos clínicos

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)