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Trial record 1 of 4 for:    buparlisib | mantle cell lymphoma
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Safety and Efficacy of BKM120 in Relapsed and Refractory NHL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01693614
Recruitment Status : Completed
First Posted : September 26, 2012
Results First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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).

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma Drug: Buparlisib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 28, 2013
Actual Primary Completion Date : July 21, 2017
Actual Study Completion Date : July 21, 2017


Arm Intervention/treatment
Experimental: DLBCL Cohort
Diffuse large B-cell lymphoma cohort
Drug: Buparlisib
100 mg hard gelatin capsules administered orally, once daily in cycles of 28 days
Other Name: BKM120

Experimental: MCL Cohort
Mantle cell lymphoma cohort
Drug: Buparlisib
100 mg hard gelatin capsules administered orally, once daily in cycles of 28 days
Other Name: BKM120

Experimental: FL Cohort
Follicular lymphoma cohort
Drug: Buparlisib
100 mg hard gelatin capsules administered orally, once daily in cycles of 28 days
Other Name: BKM120




Primary Outcome Measures :
  1. Overall Response Rate (ORR) and Disease Control Rate (DCR) Per Investigator at 6 Months (FAS) [ Time Frame: Baseline up to 6 months ]
    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


Secondary Outcome Measures :
  1. Progression- Free Survival (PFS) Based on Investigator Assessment (FAS) [ Time Frame: Baseline up to approximately 44 months ]
    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.

  2. Duration of Response for Diffuse Large B-cell Lymphoma (DLBCL), and Follicular Lymphoma (FL) Cohorts (FAS) [ Time Frame: Baseline up to approximately 18 months ]
    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

  3. Overall Survival (OS) - Percentage of Participants With OS Events (FAS) [ Time Frame: Baseline up to approximately 44 months ]
    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

  4. Percentage of Participants - Overall Survival- Kaplan Meier Estimates (FAS) [ Time Frame: Baseline up to approximately 18 months ]
    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

  5. Overall Survival - Median (FAS) [ Time Frame: Baseline up approximately 44 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693614


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Nebraska
University of Nebraska Medical Center Univ Nebraska
Omaha, Nebraska, United States, 68198
United States, New York
Memorial Sloan Kettering Dept of Onc.
New York, New York, United States, 10017
United States, South Carolina
Medical University of South Carolina -Hollings Cancer Center Medical Univ of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)
Houston, Texas, United States, 77030
Belgium
Novartis Investigative Site
Brugge, Belgium, 8000
Novartis Investigative Site
Yvoir, Belgium, 5530
France
Novartis Investigative Site
Marseille, France, 13273
Novartis Investigative Site
Pierre-Benite Cedex, France, 69495
Novartis Investigative Site
Rennes, France, 35019
Germany
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Wurzburg, Germany, 97080
Italy
Novartis Investigative Site
Milano, MI, Italy, 20133
Novartis Investigative Site
Milano, MI, Italy, 20141
Korea, Republic of
Novartis Investigative Site
Gyeonggi-do, Korea, Korea, Republic of, 10408
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 06351
Spain
Novartis Investigative Site
Salamanca, Castilla Y Leon, Spain, 37007
Novartis Investigative Site
Hospitalet de LLobregat, Catalunya, Spain, 08907
Turkey
Novartis Investigative Site
Izmir, Turkey, 35040
Novartis Investigative Site
Samsun, Turkey, 55139
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] August 9, 2016
Statistical Analysis Plan  [PDF] June 16, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01693614    
Other Study ID Numbers: CBKM120Z2402
2012-002208-41
First Posted: September 26, 2012    Key Record Dates
Results First Posted: September 28, 2018
Last Update Posted: September 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Diffuse large B-cell lymphoma, Mantle cell lymphoma, Follicular lymphoma, PI3K inhibitor, Non-Hodgkin lymphoma, NHL
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases