A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial

A Phase 2, Multicenter, Single-Arm, Open-Label Study To Determine The Efficacy And Safety Of Single-Agent Lenalidomide (Revlimid®) In Patients With Mantel Cell NHL Who Have Relapsed Or Progressed After Treatment With Bortezomib Or Are Refractory To Bortezomib

To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.

Follow up phase will continue until either 100% of the patients have died, are lost to follow up or have withdrawn consent or a maximum of 4 years from the last patient enrolled, whichever comes first. All other efficacy and safety endpoints will be updated at this time. In the unlikely event that the study will be closed and patients are still responding to treatment at this time, Celgene will discuss with the treating physicians options to provide further treatment to the patient after study closure in line with local regulation.

Follow up for second primary malignancies and OS will continue until 100% of the patients have died, are lost to follow up, have withdrawn consent, or a maximum of 5 years from the last patient enrolled, whichever comes first.

10 October 2017: In regard to the last subject last visit date/study completion date, the prolongation of timelines is due to the bridging of a treatment gap for a patient responding to study medication until non-study medication is available.

Inclusion Criteria:

• Biopsy proven mantle cell lymphoma
• Patients must have documents relapsed, refractory or PD after treatment with bortezomib
• Must have measureable disease on cross sectional imaging by CT
• Eastern Cooperative Oncology Group (ECOG) performance score 0,1 or 2
• Willing to follow pregnancy precautions

Exclusion Criteria:

• Any of the following laboratory abnormalities

  • Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L)
  • Platelet count < 60,000/mm3 (60 x 109/L)
  • Serum aspartate transaminase/Serum glutamic oxaloacetic transaminase(AST/SGOT) or alanine transaminase/Serum glutamic pyruvic transaminase (ALT/SGPT) > 3.0 x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma.
  • Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert's Syndrome and documented liver involvement by lymphoma.
  • Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL /min
  • Patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible
  • History of active central nervous system (CNS) lymphoma within the previous 3 months
  • Subjects not willing or unable to take deep vein thrombosis (DVT) prophylaxis
  • Prior history of malignancies, other than MCL, unless the patient has been free of the disease for ≥ 3 years
  • Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C