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 (relapsed) or does not respond to treatment (refractory). 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04054167.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Bouthaina Shbib Dabaja
Phone: 713-792-5132
PRIMARY OBJECTIVE:
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 radiation helps to bridge patients to other investigational drugs, by decreasing the disease bulk, controlling their symptoms, and maintaining a good performance status.
OUTLINE:
Patients undergo ultra low dose radiation for 1-2 days before chemotherapy free-targeted therapy. Patients may receive a second, longer course of radiation if the lesion treated does not respond. Patients undergo bone marrow biopsy and aspiration, position emission tomography (PET), computed tomography (CT) scan and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 6 months for up to 5 years.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorBouthaina Shbib Dabaja