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Trial record 22 of 156 for:    "Primary Central Nervous System Lymphoma"

Buparlisib (BKM120) In Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL)

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ClinicalTrials.gov Identifier: NCT02301364
Recruitment Status : Completed
First Posted : November 25, 2014
Results First Posted : October 19, 2017
Last Update Posted : October 19, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma
Primary Central Nervous System Lymphoma
Recurrent/Refractory Secondary Central Nervous System Lymphoma
Intervention Drug: Buparlisib (BKM120)
Enrollment 4
Recruitment Details Protocol Open to Accrual 11/20/2014 Protocol Closed to Accrual 03/22/2/016 Primary Completion Date 10/11/2016 Recruitment Location is the medical clinic
Pre-assignment Details  
Arm/Group Title Buparlisib (BKM120)
Hide Arm/Group Description This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Buparlisib (BKM120)
Hide Arm/Group Description This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
64
(55 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
1
  25.0%
Male
3
  75.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
4
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
4
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Progression Free Survival
Hide Description Progression-free survival (PFS) is defined as the time from the date of treatment start to the date of the first documented PD or death due to any cause. PFS will be based on the investigator’s assessment of MRI, CSF studies and clinical presentation.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buparlisib (BKM120)
Hide Arm/Group Description:
This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
Overall Number of Participants Analyzed 4
Median (Full Range)
Unit of Measure: days
39
(30 to 78)
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Adverse events be summarized based on the Common Toxicity Criteria version 4.0.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buparlisib (BKM120)
Hide Arm/Group Description:
This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival time is defined as the time from treatment start to the date of death due to any cause.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buparlisib (BKM120)
Hide Arm/Group Description:
This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
Overall Number of Participants Analyzed 4
Median (Full Range)
Unit of Measure: days
196
(54 to 284)
4.Secondary Outcome
Title Overall Response Rate
Hide Description This study will use the Macdonald criteria. Specific lesions must be evaluated serially, and comparative analysis of changes in the area of contrast enhancement, as well as the non-enhancing component, should be performed. Complete Response: Complete disappearance of all measurable and non-measurable disease. No new lesions. Partial Response: Great than or equal to 50% decrease over the baseline in the sum of products of perpendicular diameters of all measurable lesions. no progression of non-measurable disease. No new lesions. Stable/No Response: Does not qualify for CT, PR, or progression. Progressive Disease: 25% increase in the sum of products of all measureable lesions over smallest sum observes (or baseline if no decrease), OR clear clinical worsening of any non-measurable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Buparlisib (BKM120)
Hide Arm/Group Description:
This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
Partial Response
1
  25.0%
Progressive Disease
3
  75.0%
Time Frame Up to 30 days post treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Buparlisib (BKM120)
Hide Arm/Group Description This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).
All-Cause Mortality
Buparlisib (BKM120)
Affected / at Risk (%)
Total   3/4 (75.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Buparlisib (BKM120)
Affected / at Risk (%)
Total   4/4 (100.00%) 
General disorders   
Death NOS   1/4 (25.00%) 
Infections and infestations   
Infections and infestations - Other, specify   1/4 (25.00%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness right-sided   1/4 (25.00%) 
Nervous system disorders   
Dysphasia   2/4 (50.00%) 
Encephalopathy   1/4 (25.00%) 
Seizure   1/4 (25.00%) 
Psychiatric disorders   
Confusion   1/4 (25.00%) 
Depression   1/4 (25.00%) 
Hallucinations   1/4 (25.00%) 
Skin and subcutaneous tissue disorders   
Rash maculo-papular   1/4 (25.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Buparlisib (BKM120)
Affected / at Risk (%)
Total   4/4 (100.00%) 
Blood and lymphatic system disorders   
Anemia   4/4 (100.00%) 
General disorders   
Fatigue   1/4 (25.00%) 
Investigations   
Platelet count decreased   4/4 (100.00%) 
INR increased   3/4 (75.00%) 
Alanine aminotransferase increased   2/4 (50.00%) 
Blood bilirubin increased   2/4 (50.00%) 
Lymphocyte count decreased   2/4 (50.00%) 
White blood cell decreased   2/4 (50.00%) 
Alkaline phosphatase increased   1/4 (25.00%) 
Aspartate aminotransferase increased   1/4 (25.00%) 
Cholesterol high   1/4 (25.00%) 
Neutrophil count decreased   1/4 (25.00%) 
Metabolism and nutrition disorders   
Hyperglycemia   4/4 (100.00%) 
Hypoalbuminemia   3/4 (75.00%) 
Hypocalcemia   3/4 (75.00%) 
Hypokalemia   2/4 (50.00%) 
Hyponatremia   2/4 (50.00%) 
Hypernatremia   1/4 (25.00%) 
Hypoglycemia   1/4 (25.00%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness lower limb   1/4 (25.00%) 
Muscle weakness right-sided   1/4 (25.00%) 
Nervous system disorders   
Cognitive disturbance   2/4 (50.00%) 
Dysphasia   1/4 (25.00%) 
Encephalopathy   1/4 (25.00%) 
Lethargy   1/4 (25.00%) 
Memory impairment   1/4 (25.00%) 
Seizure   1/4 (25.00%) 
Psychiatric disorders   
Confusion   1/4 (25.00%) 
Depression   1/4 (25.00%) 
Hallucinations   1/4 (25.00%) 
Skin and subcutaneous tissue disorders   
Rash maculo-papular   2/4 (50.00%) 
Dry skin   1/4 (25.00%) 
Pruritus   1/4 (25.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Christian Grommes, MD
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-4058
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02301364     History of Changes
Other Study ID Numbers: 14-177
First Submitted: November 21, 2014
First Posted: November 25, 2014
Results First Submitted: August 22, 2017
Results First Posted: October 19, 2017
Last Update Posted: October 19, 2017