Safety and Efficacy of BKM120 in Relapsed and Refractory NHL

Novartis

Status and phase: Completed; Phase 2

Conditions: Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma

Treatments: Drug: Buparlisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01693614

2012-002208-41

CBKM120Z2402

Details and patient eligibility

About

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).

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 3 patient groups

DLBCL Cohort

Experimental group

Description:

Diffuse large B-cell lymphoma cohort

Treatment:

Drug: Buparlisib

MCL Cohort

Experimental group

Description:

Mantle cell lymphoma cohort

Treatment:

Drug: Buparlisib

FL Cohort

Experimental group

Description:

Follicular lymphoma cohort

Treatment:

Drug: Buparlisib