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.
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 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. After completion of study treatment, patients are followed up every 6 months for up to 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Undergo ultra low dose radiation
M D Anderson Cancer Center
Houston, Texas, United States
RECRUITINGOverall response rate (ORR)
ORR will be based on the tumors residing within the radiated field using the sum of the longest tumoral axes treated. Responses are defined as follows: i) complete response (CR): \> 75% reduction in the sum of the longest tumoral axes treated within a radiation field; ii) partial response (PR): 50 to 75% reduction; and stable disease (SD): a reduction \< 50%. Progressive disease will be defined as any relative increase in the sum of the longest tumoral axes within the radiated field. ORR will be assessed by positron emission tomography (PET)/computed tomography (CT) at 3-months after the conclusion of ultra low dose radiation (ULDR). The Lugano Classification will be used to assess tumor response. Will estimate ORR at 3 months by providing an exact 95% confidence interval for the evaluable study population.
Time frame: At 3 months
Progression-free survival (PFS)
Will be estimated at select time points of interest using the Kaplan-Meier method for all patients enrolled in the study. The origination point for time will begin at the inception of ULDR. Cox proportional hazards regression will be used to evaluate potential prognostic factors.
Time frame: From the start of ULDR treatment to the time of a progression or death, assessed up to 5 years
Overall survival
Will be estimated at select time points of interest using the Kaplan-Meier method for all patients enrolled in the study. The origination point for time will begin at the inception of ULDR. Cox proportional hazards regression will be used to evaluate potential prognostic factors.
Time frame: From the start of ULDR treatment to the time of death or loss to follow-up, assessed up to 5 years
ATM mutational status
Logistic regression will be utilized to assess the effect of patient characteristics such as ATM mutational status, on the Overall Response Rate(ORR ).
Time frame: At 3 months
PET/CT metabolic parameters
Logistic regression will be utilized to assess the effect of patient characteristics such PET/CT metabolic parameters, on the Overall Response Rate (ORR).
Time frame: At 3 months
The Descriptive Statistics of Patient Characteristics of the Transitions to other Investigational Drugs.
Will be used to summarize patient characteristics such as transitions to other investigational drugs at select time points in a patient's follow-up domain. These summaries will indicate if ULDR helps to bridge patients to other investigational drugs, by decreasing the disease bulk, controlling their symptoms, and maintaining a good performance status.
Time frame: Up to 5 years
The Descriptive Statistics of Patient Characteristics of the Patients Disease Bulk.
Will be used to summarize patient characteristics such as disease bulk at select time points in a patient's follow-up domain. These summaries will indicate if ULDR helps to bridge patients to other investigational drugs, by decreasing the disease bulk, controlling their symptoms, and maintaining a good performance status.
Time frame: Up to 5 years
The Descriptive Statistics of Patient Characteristics of the Patients Symptoms.
Will be used to summarize patient characteristics such as symptoms at select time points in a patient's follow-up domain. These summaries will indicate if ULDR helps to bridge patients to other investigational drugs, by decreasing the disease bulk, controlling their symptoms, and maintaining a good performance status.
Time frame: Up to 5 years
The Descriptive Statistics of Patient Characteristics of the Patients Performance status
Will be used to summarize patient characteristics such as performance status at select time points in a patient's follow-up domain. These summaries will indicate if ULDR helps to bridge patients to other investigational drugs, by decreasing the disease bulk, controlling their symptoms, and maintaining a good performance status.
Time frame: Up to 5 years
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