Sequential Chemotherapy and Lenalidomide Followed by Rituximab and Lenalidomide Maintenance for Untreated Mantle Cell Lymphoma

Prior treatment

• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Patients planned for upfront consolidation with high-dose therapy and autologous stem cell transplant.

Other illness

• Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
• Patients using ≥20 mg/day of prednisone (or steroid equivalent dose) for any chronic medical condition
• Known seropositive, requiring anti-viral therapy, and with detectable viral load by PCR for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
• Known hypersensitivity to thalidomide or lenalidomide

Lab values

• Uncontrolled or severe cardiovascular disease or left ventricular ejection fraction \<50% as determined by echocardiogram or MUGA.
• Pregnant or breast-feeding. Pre-menopausal patients must have a negative serum HCG within 14 days of enrollment.

Other

• Known central nervous system (CNS) lymphoma

• Previously untreated mantle cell lymphoma patients (at least clinical stage 2)
• Histologic diagnosis confirmed by MSKCC pathologist as mantle cell lymphoma
• Presence of evaluable disease
• Age ≥18 years KPS ≥ 70%
• Adequate organ function: ANC ≥1500 and platelet count ≥100,000, unless felt to be secondary to underlying mantle cell lymphoma
• Renal function assessed by calculated creatinine clearance as follows:
• Cockcroft-Gault estimation of CrCl):
  • Calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula. See section below, "Dosing Regimen", regarding lenalidomide dose adjustment for calculated creatinine clearance ≥30ml/min and \< 60ml/min.
• Adequate hepatic function as determined by
  • Total bilirubin \<1.5X upper limit of normal (ULN) (unless known Gilbert syndrome)
  • AST (SGOT) and ALT (SGPT) 3 x ULN
• All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
• Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
• Each subject must sign an informed consent form indicating that he or she understand the purpose of and procedures required for the study and are willing to participate.
• Short course systemic corticosteroids is permissible for disease control, improvement of performance status or non-cancer indication if ≤ 10 days and must be discontinued prior to study treatment.