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Spots Global Cancer Trial Database for Buparlisib in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

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Trial Identification

Brief Title: Buparlisib in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Official Title: A Pilot Study of the PI3K Inhibitor BKM120 in Patients With Relapsed Lymphoma

Study ID: NCT01719250

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mayo Clinic, Rochester, Minnesota, United States

Contact Details

Name: Thomas Witzig

Affiliation: Mayo Clinic

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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