SNPMiner Trials (Home Page)
Report for Mutation C481R
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 A Phase II Study of Acalabrutinib in Ibrutinib-Intolerant Mantle Cell Lymphoma
This phase II trial studies how well acalabrutinib works in treating patients with mantle cell lymphoma that cannot tolerate ibrutinib. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
NCT04189757 Mantle Cell Lymphoma Drug: Acalabrutinib MeSH:Lymphoma Lymphoma, Mantle-Cell
HPO:Lymphoma
BTK C481S, C481R mutations) - Progressive disease while on ibrutinib therapy. --- C481S --- --- C481R ---
Primary Outcomes
Description: The primary end point will be met if > 50% patients attain response (half of patients responding without intolerance). Logistic regression may be utilized to assess the effect of patient prognostic factors on the response rate. Intent-to-treat analysis will be applied to the eligible patients.
Measure: Overall response rate (complete response + partial response) Time: At the end of cycle 3 (each cycle is 28 days)Secondary Outcomes
Description: Logistic regression may be utilized to assess the effect of patient prognostic factors on the incidence of adverse events. Toxicity and safety data will be summarized by frequency tables for all patients and then will be reviewed for relatedness to acalabrutinib. Per-treated analysis will be performed to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received. Also, time to event and time to event resolution will be calculated.
Measure: Incidence of adverse events Time: At the end of cycle 3 (each cycle is 28 days)Description: The distribution of time-to-event endpoints including progression free survival will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.
Measure: Progression free survival Time: Up to 6 yearsDescription: The distribution of time-to-event endpoints including overall survival will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test.
Measure: Overall survival Time: Up to 6 years