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NCT00517699 · OUTCOME

Percentage of Participants With a CR, CRu or Partial Response (PR)

A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma. · Source last updated 2014-08-08

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

PR: greater than or equal to (≥) 50 percent (%) decrease in the contrast-enhancing lesion seen on MRI as compared with the baseline images; (2) Corticosteroid dose was irrelevant to the determination of PR; for participants with ocular disease, ophthalmologic exam must show a decrease in vitreous cell count or retina/optic nerve cellular infiltrate but may have continued to show persistent malignant or suspicious cells; for participants with CSF positive for neoplastic cells, CSF cytology may be negative or continue to show persistent malignant or suspicious cells in patients with ≥50% decrease in the primary brain lesions; no new sites of disease.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Rituximab, Cytarabine, and MTX0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
PR: greater than or equal to (≥) 50 percent (%) decrease in the contrast-enhancing lesion seen on MRI as compared with the baseline images; (2) Corticosteroid dose was irrelevant to the determination of PR; for participants with ocular disease, ophthalmologic exam must show a decrease in vitreous cell count or retina/optic nerve cellular infiltrate but may have continued to show persistent malignant or suspicious cells; for participants with CSF positive for neoplastic cells, CSF cytology may be negative or continue to show persistent malignant or suspicious cells in patients with ≥50% decrease in the primary brain lesions; no new sites of disease.
groups
  1. 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 CR, CRu or Partial Response (PR)
type
PRIMARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice