Safety and Efficacy of BKM120 in Relapsed and Refractory NHL
NCT ID: NCT01693614
Last Updated: 2018-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2013-02-28
2017-07-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DLBCL Cohort
Diffuse large B-cell lymphoma cohort
Buparlisib
100 mg hard gelatin capsules administered orally, once daily in cycles of 28 days
MCL Cohort
Mantle cell lymphoma cohort
Buparlisib
100 mg hard gelatin capsules administered orally, once daily in cycles of 28 days
FL Cohort
Follicular lymphoma cohort
Buparlisib
100 mg hard gelatin capsules administered orally, once daily in cycles of 28 days
Interventions
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Buparlisib
100 mg hard gelatin capsules administered orally, once daily in cycles of 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
University of Nebraska Medical Center Univ Nebraska
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
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Würzburg, , Germany
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Gyeonggi-do, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Salamanca, Castille and León, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, Spain
Novartis Investigative Site
Izmir, , Turkey (Türkiye)
Novartis Investigative Site
Samsun, , Turkey (Türkiye)
Countries
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References
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Younes A, Salles G, Martinelli G, Bociek RG, Barrigon DC, Barca EG, Turgut M, Gerecitano J, Kong O, Pisal CB, Tavorath R, Kim WS. Pan-phosphatidylinositol 3-kinase inhibition with buparlisib in patients with relapsed or refractory non-Hodgkin lymphoma. Haematologica. 2017 Dec;102(12):2104-2112. doi: 10.3324/haematol.2017.169656. Epub 2017 Sep 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2012-002208-41
Identifier Type: -
Identifier Source: secondary_id
CBKM120Z2402
Identifier Type: -
Identifier Source: org_study_id
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