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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
100 mg hard gelatin capsules administered orally, once daily in cycles of 28 days
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Nebraska Medical Center Univ Nebraska
Overall Response Rate (ORR) and Disease Control Rate (DCR) Per Investigator at 6 Months (FAS)
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
Time frame: Baseline up to 6 months
Progression- Free Survival (PFS) Based on Investigator Assessment (FAS)
Progression-free survival (PFS) is the time from the date of treatment start to the date of the first documented progressive disease (PD) or death due to any cause using Kaplan-Meier method by cohort.
Time frame: Baseline up to approximately 44 months
Duration of Response for Diffuse Large B-cell Lymphoma (DLBCL), and Follicular Lymphoma (FL) Cohorts (FAS)
Duration of response is the time from the date of first occurrence of complete response (CR) or partial response (PR) to the date of the first documented progressive disease (PD) or death due to any cause
Time frame: Baseline up to approximately 18 months
Overall Survival (OS) - Percentage of Participants With OS Events (FAS)
Overall survival (OS) is the time from treatment start to the date of death due to any cause. Participants not known to have died were censored at the date of their last visit
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Omaha, Nebraska, United States
Memorial Sloan Kettering Dept of Onc.
New York, New York, United States
Medical University of South Carolina -Hollings Cancer Center Medical Univ of South Carolina
Charleston, South Carolina, United States
University of Texas MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)
Houston, Texas, United States
Novartis Investigative Site
Bruges, Belgium
Novartis Investigative Site
Yvoir, Belgium
Novartis Investigative Site
Marseille, France
Novartis Investigative Site
Pierre-Bénite, France
Novartis Investigative Site
Rennes, France
...and 10 more locations
Time frame: Baseline up to approximately 44 months
Percentage of Participants - Overall Survival- Kaplan Meier Estimates (FAS)
Overall survival (OS) is the time from treatment start to the date of death due to any cause. Estimates done by cohort using Kaplan-Meier method with 95% confidence intervals
Time frame: Baseline up to approximately 18 months
Overall Survival - Median (FAS)
Overall survival (OS) is the time from treatment start to the date of death due to any cause. Estimates done by cohort using Kaplan-Meier method with 95% confidence intervals
Time frame: Baseline up approximately 44 months