Safety and Efficacy of BKM120 in Relapsed and Refractory NHL

Inclusion criteria

• Patient had a histologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma, or diffuse large B cell lymphoma.
• Patient had relapsed or refractory disease and received at least one prior therapy.
• Patient with diffuse large B cell lymphoma had received or was ineligible for autologous or allogeneic stem cell transplant.
• Patient had at least one measurable nodal lesion (≥2 cm) according to Cheson criteria (Cheson 2007). In case where the patient had no measurable nodal lesions ≥ 2 cm in the long axis at baseline, then the patient must have had at least one measurable extra-nodal lesion.
• Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Patient had adequate bone marrow and organ function.

Exclusion criteria

• Patient had received previous treatment with PI3K inhibitors
• Patient had evidence of graft versus host disease (GVHD).
• Patient had active or history of central nervous system (CNS) disease.
• Patient had a concurrent malignancy or had a malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer).
• Patient had a score ≥ 12 on the PHQ-9 questionnaire.
• Patient had a GAD-7 mood scale score ≥ 15.
• Pregnant or nursing women
• Patient who did not use highly effective contraception methods to avoid becoming pregnant or conceiving offspring.