Trial Outcomes & Findings for Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Primary Central Nervous System Non-Hodgkin Lymphoma (NCT NCT01973062)
NCT ID: NCT01973062
Last Updated: 2020-07-24
Results Overview
Number of patients with at least a 50% reduction in tumor size on a MRI scan with stable or decreasing dose of corticosteroids
TERMINATED
PHASE2
1 participants
Up to 2 years
2020-07-24
Participant Flow
Participant milestones
| Measure |
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
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 Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Primary Central Nervous System Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
n=1 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Only one patient registered. No patient data analyzed
Number of patients with at least a 50% reduction in tumor size on a MRI scan with stable or decreasing dose of corticosteroids
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only one patient registered. No patient data analyzed
The number of patients without an unequivocal increase in tumor size or the appearance of new lesions by MRI
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Only one patient registered. No patient data analyzed
The number of patients alive up to two years after treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days following the last dose of study treatmentPopulation: Only one patient registered. No patient data analyzed
Number of patients with toxicities related to the study drug
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At day 11Population: Only one patient registered. No patient data analyzed
Number of Gy delivered to each tumor as calculated using the MIRD dosimetry formula on PET data
Outcome measures
Outcome data not reported
Adverse Events
Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place