TriangleNCT00517699 · OUTCOME
Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Week 24
What was measured
CR: complete disappearance of all enhancing abnormalities on contrast-enhanced cranial magnetic resonance imaging (MRI); no evidence of active ocular lymphoma as defined by absence of cells in the vitreous and resolution of any previously documented retinal or optic nerve infiltrates; negative cerebrospinal fluid (CSF) cytology; at the time of CR determination, participant had discontinued use of all corticosteroids for at least 2 weeks. CRu requires fulfillment of CR criteria but with these limitations: Fulfills CR criteria but had continued requirement for corticosteroid therapy at any dose; small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; persistent minor abnormality on follow-up ophthalmologic exam (related to persistent non-malignant cells in vitreous, or alterations in retina/optic nerve not consistent with tumor infiltration) if the abnormality is unlikely to represent ocular lymphoma.
Analysis population: Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.
Groups in this outcome
Rituximab, Cytarabine, and MTX
Participants received single doses of rituximab 750 mg/m\^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m\^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m\^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
| Group | Source count |
|---|---|
| Rituximab, Cytarabine, and MTX | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- CR: complete disappearance of all enhancing abnormalities on contrast-enhanced cranial magnetic resonance imaging (MRI); no evidence of active ocular lymphoma as defined by absence of cells in the vitreous and resolution of any previously documented retinal or optic nerve infiltrates; negative cerebrospinal fluid (CSF) cytology; at the time of CR determination, participant had discontinued use of all corticosteroids for at least 2 weeks. CRu requires fulfillment of CR criteria but with these limitations: Fulfills CR criteria but had continued requirement for corticosteroid therapy at any dose; small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; persistent minor abnormality on follow-up ophthalmologic exam (related to persistent non-malignant cells in vitreous, or alterations in retina/optic nerve not consistent with tumor infiltration) if the abnormality is unlikely to represent ocular lymphoma.
- groups
- description
- Participants received single doses of rituximab 750 mg/m\^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m\^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m\^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
- id
- OG000
- title
- Rituximab, Cytarabine, and MTX
- population Description
- Due to early study termination, all efficacy data were documented by data listings only, no data analysis was performed.
- reporting Status
- POSTED
- time Frame
- Week 24
- title
- Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu)
- type
- PRIMARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice