A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma

• Duration of Response as Determined by Central Review [ Time Frame: Up to 1459 days ] [ Designated as safety issue: No ]

  Kaplan-Meier estimates for the duration of response were calculated for responders and defined as the time from at least a partial response (PR) to progression of disease (PD) or death due to Non-Hodgkin's lymphoma.

  For response assessment criteria (per Cheson, 1999) see the primary outcome measure in this results posting.

• Time to Progression as Determined by Central Review [ Time Frame: Up to 1459 days ] [ Designated as safety issue: No ]

  Kaplan-Meier estimate of time-to-progression is calculated as time from the start of study drug therapy to the first observation of disease progression.

  Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.

  • Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.
• Progression-free Survival as Determined by Central Review [ Time Frame: Up to 1459 days ] [ Designated as safety issue: No ]

  Kaplan-Meier estimate of progression-free survival is defined as start of study drug therapy to the first observation of progressive disease or death due to any cause, whichever comes first.

  Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.

  • Progressive Disease(PD): Appearance of new lesion during/end of therapy; >=50% increase from lowest measurement in SPD.
• Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review [ Time Frame: Up to 1459 days ] [ Designated as safety issue: No ]

  Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article.

  • Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy.
  • Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow.
  • Partial Response(PR): >50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson.
  • Stable Disease(SD): Less than PR, but not progressive disease.

Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop

Key Inclusion criteria

• Biopsy proven aggressive non-hodgkin's lymphoma

  • Follicular center lymphoma Grade 3.
  • Diffuse large B-cell lymphoma.
  • Mantle cell lymphoma.
  • Transformed lymphoma.
• Relapsed or refractory to previous therapy for lymphoma
• At least one prior combination chemotherapy regime
• Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
• Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2
• Willing to follow the pregnancy precautions

Key Exclusion criteria

• Any of the following laboratory abnormalities.

  • Absolute neutrophil count (ANC) < 1,500 cells/mm^3 (1.5*10^9/L).
  • Platelet count < 60,000/mm^3 (60*10^9/L).
  • Calculated creatinine clearance of <50mL/min
  • Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) or Serum glutamic pyruvic transaminase/Alanine transaminase (SGPT/ALT) 5.0 times upper limit of normal (ULN).
  • Serum total bilirubin > 2.0 mg/dL (34 µmol/L)/conjugated bilirubin >0.8mg/dL.
• Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
• History of active Central Nervous System (CNS) lymphoma within the previous 6 months
• History of other malignancies within the past year
• Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C