Phase II Trial to Assess the Efficacy of Ultra Low Radiation Dose Delivered Prior or After Chemotherapy Free Targeted Therapy for the Treatment of Relapsed/Refractory Mantle Cell Lymphoma
This phase II trial studies how well ultra low dose radiation works before or after chemotherapy-free targeted therapy in treating patients with mantle cell lymphoma that has come back or does not respond to treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Ultra low dose radiation is generally associated with a lower risk of side effects which may allow patients to be able to receive low-dose radiation therapy more often than high-dose radiation therapy. This trial may help doctors learn if giving ultra low dose radiation helps control mantle cell lymphoma and improves response to chemotherapy free targeted therapy.
• Patients must have a confirmed diagnosis of mantle cell lymphoma with positivity in tissue biopsy. Biopsy does not need to be done of the lesions to be treated.
• Patients can be newly diagnosed or previously treated relapsed and/or refractory MCL.
• Understand and voluntarily sign an IRB-approved informed consent form.
• Age ≥ 18 years at the time of signing the informed consent.
• Patients must have bi-dimensional measurable disease (Measurable disease by CT scan defined as at least 1 lesion that measures =/\>1.5 cm in single dimension.) Patient presenting with lesions in the presence of leukemia phase (peripheral blood involvement), non-measurable disease, gastrointestinal (GI) MCL, or bone marrow (BM) MCL are also eligible.
• Gastrointestinal or bone marrow or spleen only patients are allowable and will be analyzed separately.
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (see Appendix 1).
• Willing and able to participate in all study related procedures and therapy including swallowing capsules without difficulty.
• Females of childbearing potential (FCBP)1 must have a negative serum or urine pregnancy test and must be willing to use acceptable methods of birth control during the study and for 30 days after the last dose of study treatment.
• Male patients must use an effective barrier method of contraception during the study and for 30 days following the last dose of study treatment if sexually active with a female of childbearing potential.
• Serum bilirubin \<1.5 mg/dl and Cr Clearance ≥ 30 mL/min, platelet count \>25,000/mm3 and absolute neutrophil count (ANC) \> 1,000/mm3, AST (SGOT) and ALT (SGPT) \< 3 x upper limit of normal or \< 5 x upper limit of normal if hepatic metastases are present.
• Patients who have bone marrow infiltration by MCL are eligible if their ANC is ≥ 1000/mm3 \[growth factor not allowed\] or their platelet level is ≥ 25,000/mm3