A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

• Status: Completed
• Trial end date: 2018-10-09
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory mantle cell lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Fludarabine; Fludarabine phosphate; Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Biopsy proven mantle cell lymphoma

• Patients who are refractory to their regimen or have relapsed once, twice or up to three times and who have documented progressive disease

• Eastern Cooperative Oncology Group (ECOG) performance score 0,1, or 2

• Willing to follow pregnancy precaution

Exclusion Criteria:

• Any of the following laboratory abnormalities

• Absolute neutrophil count (ANC) < 1,500 cells/mm^3 (1.5 x 10^9/L)

• Platelet count < 60,000/mm^3 (60 x 10^9/L)

• Serum aspartate transaminase/serum glutamic oxaloacetic transaminase(AST/SGOT) or alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >3.0 x upper limit or normal (ULN), except patients with documented liver involvement by lymphoma

• Serum total bilirubin > 1.5 x ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma.

• Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL/min

• History of active central nervous system (CNS) lymphoma within the previous 3 months

• Subjects not willing to take deep venous thrombosis (DVT) prophylaxis

• Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are sero-positive because of hepatitis B virus vaccine are eligible