Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT01719250
Brief Summary:
This pilot clinical trial studies how well buparlisib works in treating patients with non-Hodgkin lymphoma that has returned after a period of improvement or has not responded to previous treatment. Buparlisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
TERTIARY OBJECTIVES:
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:
NCT01719250
Study Brief:
Protocol Section:
NCT01719250