A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL).
Condition: Mantle Cell Lymphoma; Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell
Intervention: Lenalidomide; Placebo
Intervention description: 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.; Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Intervention MeSH terms: Lenalidomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mantle Cell Lymphoma; Non-Hodgkin's Lymphoma; CC-5013; Revlimid; Lenalidomide

Summary:

      A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of
      first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not
      candidates for transplantation and have achieved partial response (PR) or complete response
      (CR).

      This study was prematurely terminated by the sponsor in light of new unpublished data that
      rendered the current design of the study no longer clinically relevant. A study design with
      the control arm of no active treatment was no longer appropriate. The termination of the
      trial was not based on any safety concerns in the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically-proven mantle cell non-Hodgkin's lymphoma,

          -  One of the following first-line induction chemotherapy regimens with rituximab: (1)
             combination regimen containing all of the following components: cyclophosphamide,
             vincristine, adriamycin and a glucocorticoid; (2) Fludarabine containing regimen such
             as FC (fludarabine, cyclophosphamide)

          -  Achieved a PR or better response after the first-line induction chemotherapy regimen
             (assessed by 2007 Revised Response Criteria for Malignant Lymphoma)

          -  ECOG performance status score of ≤ 2

          -  Willing to follow pregnancy precaution

        Exclusion Criteria:

          -  Patients who have received more than 1 line of induction chemotherapy;

          -  Patients who have received less than 4 cycles of R-CHOP, R-CHOP-like, or R-FC are
             ineligible;

          -  Patients who achieved stable disease or progressive disease as best response with
             first line-induction chemotherapy;

          -  Any of the following laboratory abnormalities:

          -  Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5*10^9/L)

          -  Platelet count < 60,000/mm^3 (60*10^9/L)

          -  Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT)) > 3.0
             times upper limit of normal (ULN), except in patients with documented liver
             involvement by lymphoma

          -  Serum bilirubin > 1.5 times ULN, except in case of Gilbert's Syndrome and documented
             liver involvement by lymphoma

          -  Calculated creatinine clearance (i.e. Cockcroft-Gault formula) of < 30 mL /min

          -  Active or any history of central nervous system (CNS) lymphoma or leptomeningeal
             involvement by lymphoma

          -  Subjects at high risk for deep vein thrombosis (DVT) not willing to take DVT
             prophylaxis

          -  Known seropositive for or active viral infection with human immunodeficiency virus
             (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)