Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01693614 | Safety and Efficacy of BKM120 in Relapsed and Refractory NHL | PHASE2 | COMPLETED | 72 | — | — | Feb 28, 2013 | Jul 21, 2017 | Sep 28, 2018 | 20 | United States, Belgium +6 |
Overall Response rate is the percentage of patients in a cohort who experienced either complete response (CR) or partial response (PR) during their follow-up after treatment start divided by the total percentage of patients included in the corresponding cohort according to Cheson criteria The analysis for each cohort was based on an exact binomial test comparing the ORR to the reference level of 10% (null hypothesis) in the FAS. The test for each cohort used a significance level of 5%. The ORR was presented together with an exact 95% Clopper- Pearson confidence interval. Disease Control Rate (DCR progressive. Disease Control Rate (DCR) was the percentage of patients with CR, PR or SD (stable disease). Patients for whom the best response after treatment start was missing, unknown (UNK) or progressive disease (PD) were considered non-responders and were counted in the denominator for the estimation of the ORR
| Arm | Type | Description |
|---|---|---|
| DLBCL Cohort | EXPERIMENTAL | Diffuse large B-cell lymphoma cohort |
| MCL Cohort | EXPERIMENTAL | Mantle cell lymphoma cohort |
| FL Cohort | EXPERIMENTAL | Follicular lymphoma cohort |
| Name | Type | Description |
|---|---|---|
| Buparlisib | DRUG | 100 mg hard gelatin capsules administered orally, once daily in cycles of 28 days |
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 o...