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NCT00248534 · OUTCOME

Percentage of Participants With Objective Response

Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin's Lymphoma · Source last updated 2018-09-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percent of participants
Interval / dispersion
95% Confidence Interval
Time frame
2 months

What was measured

Objective response rate of the combination of Rituximab and TMZ

Analysis population: 2 patients were not evaluable, one died prematurely and the other withdrew consent before the first scan (during induction cycle)

Groups in this outcome

IV Rituximab

IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks. Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide \[TMZ\] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression rituximab: given IV days 1,8, 15 and 22 methylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles) temozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles

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

Analysis denominator · Participants

GroupSource count
IV Rituximab14

Reported measurements

Source class 1
Values in percent of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IV Rituximab14Not reported243Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        43
        value
        14
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    units
    Participants
description
Objective response rate of the combination of Rituximab and TMZ
dispersion Type
95% Confidence Interval
groups
  1. description
    IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks. Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide \[TMZ\] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression rituximab: given IV days 1,8, 15 and 22 methylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles) temozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles
    id
    OG000
    title
    IV Rituximab
param Type
NUMBER
population Description
2 patients were not evaluable, one died prematurely and the other withdrew consent before the first scan (during induction cycle)
reporting Status
POSTED
time Frame
2 months
title
Percentage of Participants With Objective Response
type
PRIMARY
unit Of Measure
percent of participants

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

Preserved source evidence · Not medical advice