Buparlisib in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Other: laboratory biomarker analysis
Other: questionnaire administration
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of the PI3K Inhibitor BKM120 in Patients With Relapsed Lymphoma|
- Clinical benefit defined as a PR or CR as the objective status at any time or an objective status of SD for a duration of greater than 6 months from registration [ Time Frame: From 6 months from registration up to 1 year ] [ Designated as safety issue: No ]The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent binomial confidence intervals for the true success proportion will be calculated.
- Survival time [ Time Frame: From registration to death due to any cause, assessed up to 1 year ] [ Designated as safety issue: No ]Will be estimated using the method of Kaplan-Meier.
- Progression-free survival time [ Time Frame: From registration to progression or death due to any cause, assessed up to 1 year ] [ Designated as safety issue: No ]Will be estimated using the method of Kaplan-Meier.
- Overall response rate estimated by the number of confirmed responses (PR or CR) observed in the trial divided by the total number of evaluable patients [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]Exact binomial 95% confidence intervals for the true overall response rate will be calculated.
- Duration of response [ Time Frame: From the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented, assessed up to 1 year ] [ Designated as safety issue: No ]If an adequate number of events are seen, the distribution of duration of response will be estimated using the method of Kaplan-Meier. Otherwise, duration of response will be summarized descriptively.
- Prognostic factors for aggressive lymphoma [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]Will be summarized and used to help characterize the types of patients accrued to this trial. These classifications will be correlated with clinical benefit using Fisher's exact or Wilcoxon rank sum tests.
|Study Start Date:||December 2012|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (buparlisib)
Patients receive buparlisib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Names:Other: laboratory biomarker analysis
Correlative studiesOther: questionnaire administration
I. To evaluate the clinical benefit rate (complete response [CR], partial response [PR] or standard disease [SD] >= 6 months) with BKM120 (buparlisib) in patients with relapsed or refractory lymphoma.
I. To evaluate overall response rate, overall survival, progression-free survival and duration of response.
II. To describe the toxicities associated with BKM120 in lymphoma. III. To evaluate prognostic factors for aggressive lymphoma and whether there's a correlation with clinical benefit.
I. To assess serum cytokines before and after BKM120 therapy. II. To assess phosphatidylinositol 3-kinase (PI3K) pathway member expression on paraffin-embedded tumor samples pre-treatment.
III. To assess on paired fresh tumor tissue obtained from consenting patients pre- and post-therapy the change in activation of PI3K pathway members.
OUTLINE: Patients receive buparlisib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719250
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Thomas Witzig||Mayo Clinic|