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Trial record 74 of 156 for:    "Primary Central Nervous System Lymphoma"

Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Primary Central Nervous System Non-Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT01973062
Recruitment Status : Terminated (Funding Unavailable)
First Posted : October 31, 2013
Results First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Central Nervous System Non-Hodgkin Lymphoma
Interventions Biological: rituximab
Radiation: yttrium Y 90 ibritumomab tiuxetan
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Hide Arm/Group Description

Patients receive rituximab IV on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

yttrium Y 90 ibritumomab tiuxetan: Given IV

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Hide Arm/Group Description

Patients receive rituximab IV on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

yttrium Y 90 ibritumomab tiuxetan: Given IV

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 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
1
 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 1 participants
1
1.Primary Outcome
Title Radiographic Response Assessed by MRI or FDG-PET/MRI
Hide Description Number of patients with at least a 50% reduction in tumor size on a MRI scan with stable or decreasing dose of corticosteroids
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient registered. No patient data analyzed
Arm/Group Title Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Hide Arm/Group Description:

Patients receive rituximab IV on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

yttrium Y 90 ibritumomab tiuxetan: Given IV

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Progression Free Survival
Hide Description The number of patients without an unequivocal increase in tumor size or the appearance of new lesions by MRI
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient registered. No patient data analyzed
Arm/Group Title Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Hide Arm/Group Description:

Patients receive rituximab IV on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

yttrium Y 90 ibritumomab tiuxetan: Given IV

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival
Hide Description The number of patients alive up to two years after treatment
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient registered. No patient data analyzed
Arm/Group Title Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Hide Arm/Group Description:

Patients receive rituximab IV on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

yttrium Y 90 ibritumomab tiuxetan: Given IV

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Establish the Toxicity Profile of Ibritumomab Tiuxetan in This Patient Population.
Hide Description Number of patients with toxicities related to the study drug
Time Frame Up to 30 days following the last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient registered. No patient data analyzed
Arm/Group Title Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Hide Arm/Group Description:

Patients receive rituximab IV on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

yttrium Y 90 ibritumomab tiuxetan: Given IV

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Dosimetry Calculations of Yttrium Y 90 Ibritumomab Tiuxetan Assessed by PET/MRI
Hide Description Number of Gy delivered to each tumor as calculated using the MIRD dosimetry formula on PET data
Time Frame At day 11
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient registered. No patient data analyzed
Arm/Group Title Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Hide Arm/Group Description:

Patients receive rituximab IV on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

yttrium Y 90 ibritumomab tiuxetan: Given IV

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Hide Arm/Group Description

Patients receive rituximab IV on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

yttrium Y 90 ibritumomab tiuxetan: Given IV

All-Cause Mortality
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Affected / at Risk (%)
Total   1/1 (100.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Affected / at Risk (%)
Total   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Manmeet Ahluwalia, MD
Organization: Case Comprehensive Cancer Center
Phone: 216-444-6145
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01973062     History of Changes
Other Study ID Numbers: CASE4413
NCI-2013-01993 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA043703 ( U.S. NIH Grant/Contract )
First Submitted: October 25, 2013
First Posted: October 31, 2013
Results First Submitted: June 25, 2018
Results First Posted: July 20, 2018
Last Update Posted: July 20, 2018