Phase 2
N=72
Safety and Efficacy of BKM120 in Relapsed and Refractory NHL
Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01693614 ↗Enrolled (actual)
72
Serious AEs
43.1%
Results posted
Sep 2018
Primary outcome: Primary: Overall Response Rate (ORR) and Disease Control Rate (DCR) Per Investigator at 6 Months (FAS) — 11.5; 22.7; 25.0; 30.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Buparlisib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) and Disease Control Rate (DCR) Per Investigator at 6 Months (FAS) |
11.5; 22.7; 25.0; 30.8; 81.8; 87.5 | — |
| SECONDARY Progression- Free Survival (PFS) Based on Investigator Assessment (FAS) |
1.8; 11.3; 9.1 | — |
| SECONDARY Duration of Response for Diffuse Large B-cell Lymphoma (DLBCL), and Follicular Lymphoma (FL) Cohorts (FAS) |
2.2; 11.0 | — |
| SECONDARY Overall Survival (OS) - Percentage of Participants With OS Events (FAS) |
50.0; 22.7; 8.3; 50.0; 77.3; 91.7 | — |
| SECONDARY Percentage of Participants - Overall Survival- Kaplan Meier Estimates (FAS) |
83.6; 100.0; 100.0; 66.9; 90.2; 100.0 | — |
| SECONDARY Overall Survival - Median (FAS) |
5.2; NA; NA | — |
Summary
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01693614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.