Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Pilot Study of the PI3K Inhibitor BKM120 in Patients With Relapsed Lymphoma
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.
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.
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