Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00267865 · OUTCOME

Change From Baseline in Cluster of Differentiation 4 (CD4) T Cell Count at up to 2.5 Years

Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma · Source last updated 2020-06-01

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

Measure
MEDIAN
Unit
cells/µL
Interval / dispersion
Full Range
Time frame
Baseline and up to 2.5 years

What was measured

An increase in CD4 cells is determined by the number of CD4+ T lymphocytes /µL of peripheral blood.

Analysis population: Two participants were not evaluable. One participant received one cycle of therapy and one was not evaluable due to treatment failure.

Groups in this outcome

Rituximab, High-Dose Methotrexate & Leucovorin Treatment

Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy. Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour. Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes

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, High-Dose Methotrexate & Leucovorin Treatment10

Reported measurements

Source class 1
Values in cells/µL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Rituximab, High-Dose Methotrexate & Leucovorin Treatment35Not reported-54369Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -54
        upper Limit
        369
        value
        35
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
An increase in CD4 cells is determined by the number of CD4+ T lymphocytes /µL of peripheral blood.
dispersion Type
Full Range
groups
  1. description
    Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy. Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour. Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
    id
    OG000
    title
    Rituximab, High-Dose Methotrexate & Leucovorin Treatment
param Type
MEDIAN
population Description
Two participants were not evaluable. One participant received one cycle of therapy and one was not evaluable due to treatment failure.
reporting Status
POSTED
time Frame
Baseline and up to 2.5 years
title
Change From Baseline in Cluster of Differentiation 4 (CD4) T Cell Count at up to 2.5 Years
type
SECONDARY
unit Of Measure
cells/µL

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

Preserved source evidence · Not medical advice