Safety and Efficacy of BKM120 in Relapsed and Refractory NHL

An Open-label Phase II Study of BKM120 in Subjects With Relapsed and Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma and Follicular Lymphoma

This is a phase II study evaluating the safety, tolerability and efficacy of BKM120 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or follicular lymphoma (FL).

Inclusion Criteria:

1. Patient had a histologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma, or diffuse large B cell lymphoma.
2. Patient had relapsed or refractory disease and received at least one prior therapy.
3. Patient with diffuse large B cell lymphoma had received or was ineligible for autologous or allogeneic stem cell transplant.
4. 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.
5. Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
6. Patient had adequate bone marrow and organ function.

Exclusion Criteria:

1. Patient had received previous treatment with PI3K inhibitors
2. Patient had evidence of graft versus host disease (GVHD).
3. Patient had active or history of central nervous system (CNS) disease.
4. 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).
5. Patient had a score ≥ 12 on the PHQ-9 questionnaire.
6. Patient had a GAD-7 mood scale score ≥ 15.
7. Pregnant or nursing women
8. Patient who did not use highly effective contraception methods to avoid becoming pregnant or conceiving offspring.