Buparlisib in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT01719250|
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : October 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Refractory Mantle Cell Lymphoma Transformed Recurrent Non-Hodgkin Lymphoma||Drug: Buparlisib Other: Laboratory Biomarker Analysis Other: Questionnaire Administration||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of the PI3K Inhibitor BKM120 in Patients With Relapsed Lymphoma|
|Actual Study Start Date :||December 2012|
|Actual Primary Completion Date :||September 16, 2016|
|Actual Study Completion Date :||March 22, 2017|
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: Laboratory Biomarker Analysis
Other: Questionnaire Administration
- 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 ]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.
- 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 ]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.
- 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 ]Exact binomial 95% confidence intervals for the true overall response rate will be calculated.
- Prognostic factors for aggressive lymphoma [ Time Frame: Up to 1 year ]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.
- Progression-free survival time [ Time Frame: Time from registration to progression or death due to any cause, assessed up to 1 year ]Will be estimated using the method of Kaplan-Meier.
- Survival time [ Time Frame: Time from registration to death due to any cause, assessed up to 1 year ]Will be estimated using the method of Kaplan-Meier.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719250
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Thomas Witzig||Mayo Clinic|