Dose Finding Study of Ibrutinib Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma

Inclusion Criteria

• •Age greater than or equal to 18 years.
• •Histologically or cytologically confirmed diagnosis of MCL.
• •Relapsed or refractory MCL patients who have received at least one prior therapy are eligible. Patients who have previously received high-dose chemotherapy with peripheral stem cell support are eligible.
• •Presence of at least one lymph node evaluable or mass measurable for response.
• •Eastern Cooperative Oncology Group Performance Status greater than 2.
• •Platelets \> 75,000/μL and absolute neutrophils count (ANC) \> 1,000/μL within 14 days of study registration (unless the treating physician deems the neutropenia is related to bone marrow involvement, then an ANC of \> 750/mm 3 is allowed)
• •Normal renal function defined as serum creatinine less than 2.
• •Recovery from any previous treatment therapy.
• •Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test
• •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.
• •Ability to understand, and willingness to sign, a written informed consent document.
• •Able to take aspirin (81 or 325 mg) daily as prophylactic anti-coagulation (patients intolerant to ASA may use low molecular weight heparin).
• •Normal organ and bone marrow function parameter:
• •Laboratory tests Required value WBC \>3000/μL\* Absolute neutrophils count \>1,000/μL\* Platelets \>75,000/μL Total bilirubin \< 1.5Within normal institutional limits AST (SGOT) and ALT (SGPT) \<3 x institutional upper limit of normal Creatinine or creatinine clearance \<1.5 within normal institutional limits \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (calculated by Cockcroft-Gault formula)