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

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out what effects, good and/or bad, the treatment including 1) Lenalidomide-RCHOP, 2) R-HIDAC, and 3) Lenalidomide-Rituximab maintenance has on the participant and their lymphoma.

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

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: Celgene Corporation
• Treatments: Cytarabine; Lenalidomide; Rituximab; Thalidomide

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Known central nervous system (CNS) lymphoma

• Uncontrolled or severe cardiovascular disease or left ventricular ejection fraction <50% as determined by echocardiogram or MUGA.

• 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.

• Pregnant or breast-feeding. Pre-menopausal patients must have a negative serum HCG within 14 days of enrollment.

• 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

• 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.