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
M.D. Anderson Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVES: I. To evaluate the efficacy of adding ultra low dose radiation (ULDR) to chemotherapy free-targeted therapy (CTFTT) in contributing to a durable overall response in treated locations by estimating overall response rate (ORR) at 3 months. SECONDARY OBJECTIVES: I. To evaluate if ULDR can improve progression-free survival and overall survival. II. To evaluate the prognostic factors associated with inferior progression-free survival, including patient related and previous treatment related and if radiation can overcome these prognostic factors. III. To evaluate if radiatio…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugLow Dose Radiation Therapy
Undergo ultra low dose radiation
Location
- M D Anderson Cancer CenterHouston, Texas