NCT01719250

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Adult Diffuse Large Cell Lymphoma
• Recurrent Grade 3 Follicular Lymphoma
• Recurrent Mantle Cell Lymphoma
• Refractory Mantle Cell Lymphoma
• Transformed Recurrent Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Buparlisib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-09-16
• Completion: 2017-03-22
• First posted: 2012-11-01
• Last updated: 2018-10-09

Locations

1 site across 1 country: United States