Clareo Health | 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).
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).
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
You may not be if
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;
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)
