- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01693614
Safety and Efficacy of BKM120 in Relapsed and Refractory NHL
August 30, 2018 updated by: Novartis Pharmaceuticals
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brugge, Belgium, 8000
- Novartis Investigative Site
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Yvoir, Belgium, 5530
- Novartis Investigative Site
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Marseille, France, 13273
- Novartis Investigative Site
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Pierre-Benite Cedex, France, 69495
- Novartis Investigative Site
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Rennes, France, 35019
- Novartis Investigative Site
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Frankfurt, Germany, 60590
- Novartis Investigative Site
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Wurzburg, Germany, 97080
- Novartis Investigative Site
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MI
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Milano, MI, Italy, 20133
- Novartis Investigative Site
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Milano, MI, Italy, 20141
- Novartis Investigative Site
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Korea
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Gyeonggi-do, Korea, Korea, Republic of, 10408
- Novartis Investigative Site
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Seoul, Korea, Korea, Republic of, 06351
- Novartis Investigative Site
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Castilla Y Leon
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Salamanca, Castilla Y Leon, Spain, 37007
- Novartis Investigative Site
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Catalunya
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Hospitalet de LLobregat, Catalunya, Spain, 08907
- Novartis Investigative Site
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Izmir, Turkey, 35040
- Novartis Investigative Site
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Samsun, Turkey, 55139
- Novartis Investigative Site
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center Univ Nebraska
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New York
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New York, New York, United States, 10017
- Memorial Sloan Kettering Dept of Onc.
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina -Hollings Cancer Center Medical Univ of South Carolina
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Texas
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Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: DLBCL Cohort
Diffuse large B-cell lymphoma cohort
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100 mg hard gelatin capsules administered orally, once daily in cycles of 28 days
Other Names:
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Experimental: MCL Cohort
Mantle cell lymphoma cohort
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100 mg hard gelatin capsules administered orally, once daily in cycles of 28 days
Other Names:
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Experimental: FL Cohort
Follicular lymphoma cohort
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100 mg hard gelatin capsules administered orally, once daily in cycles of 28 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Overall Response Rate (ORR) and Disease Control Rate (DCR) Per Investigator at 6 Months (FAS)
Time Frame: Baseline up to 6 months
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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
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Baseline up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression- Free Survival (PFS) Based on Investigator Assessment (FAS)
Time Frame: Baseline up to approximately 44 months
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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.
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Baseline up to approximately 44 months
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Duration of Response for Diffuse Large B-cell Lymphoma (DLBCL), and Follicular Lymphoma (FL) Cohorts (FAS)
Time Frame: Baseline up to approximately 18 months
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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
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Baseline up to approximately 18 months
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Overall Survival (OS) - Percentage of Participants With OS Events (FAS)
Time Frame: Baseline up to approximately 44 months
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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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Baseline up to approximately 44 months
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Percentage of Participants - Overall Survival- Kaplan Meier Estimates (FAS)
Time Frame: Baseline up to approximately 18 months
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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
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Baseline up to approximately 18 months
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Overall Survival - Median (FAS)
Time Frame: Baseline up approximately 44 months
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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
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Baseline up approximately 44 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2013
Primary Completion (Actual)
July 21, 2017
Study Completion (Actual)
July 21, 2017
Study Registration Dates
First Submitted
September 4, 2012
First Submitted That Met QC Criteria
September 24, 2012
First Posted (Estimate)
September 26, 2012
Study Record Updates
Last Update Posted (Actual)
September 28, 2018
Last Update Submitted That Met QC Criteria
August 30, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBKM120Z2402
- 2012-002208-41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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