This clinical trial collects and tests samples using genetic testing to find personalized treatments that may work best for patients with mantle cell lymphoma (MCL) that has come back (relapsed) or does not respond to treatment (refractory). Several types of MCL are difficult to treat due to specific genetic changes (mutations or alterations in the DNA/RNA expression in the cells) that make them not respond to a certain type of drug called a Bruton's tyrosine kinase (BTK) inhibitor. The goal of this clinical research study is to use genetic testing to identify which drugs may be most effective in treating patients with MCL who have this type of genetic mutation.
PRIMARY OBJECTIVE: I. To evaluate the feasibility of the proposed therapy based on dysregulated cell signaling pathways in combination with in vitro drug activity. SECONDARY OBJECTIVES: I. Overall response rates (complete response \[CR\] + partial response \[PR\]). II. Safety in patients who were treated with matched personalized therapies. III. Duration of response. IV. Progression free survival (PFS). V. Overall survival (OS). EXPLORATORY OBJECTIVE: I. Correlation of somatic mutations in MCL with cell signaling dysregulated activity and therapeutic implications of somatic mutations in relapsed MCL. OUTLINE: Patients undergo blood, saliva or tissue sample collection for messenger ribonucleic acid analysis (mRNA) analysis and drug efficacy testing. Patients assigned treatment per the results are followed every 1 cycle of therapy for 1 year, every 2 months for 1 year, every 4 months for 1 year then every 6 months thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
1
Undergo blood, saliva or tissue sample collection
Undergo follow-up
M D Anderson Cancer Center
Houston, Texas, United States
Feasibility rate
Will be reported by frequency with exact 95% confidence interval. Logistic regression will be utilized to assess the effect of patient prognostic factors on the feasibility and response rate.
Time frame: Up to 1 year
Response rate
Will be reported by frequency with exact 95% confidence interval. Logistic regression will be utilized to assess the effect of patient prognostic factors on the feasibility and response rate.
Time frame: Up to 1 year
Incidence of adverse events
Toxicity data by type and severity will be summarized by frequency tables.
Time frame: Up to 1 year
Duration of response
Time frame: Up to 1 year
Progression free survival
Will be estimated using the method of Kaplan and Meier. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.
Time frame: Up to 1 year
Overall survival
Will be estimated using the method of Kaplan and Meier. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.
Time frame: Up to 1 year
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