NCT00719472 · OUTCOME

Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle)

A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma (RATE) · Source last updated 2017-05-15

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

Measure: NUMBER
Unit: Percentage of participants
Interval / dispersion: Not reported
Time frame: Day 1 of Cycle 2 and either Cycle 6 or 8 (last cycle)

What was measured

Serum samples for measurement of CD19+ lymphocytes were taken pre-dose (within 15 minutes before rituximab infusion). CD19+ lymphocyte counts were measured by flow cytometry using a fluorescent-activated cell sorter (FACS).

Analysis population: Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1. Only patients with pre-dose CD19+ lymphocyte counts at each time point were included in the analyses.

Groups in this outcome

Rituximab 375 mg/m^2

Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin \[doxorubicin\], Oncovin \[vincristine\], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m\^2 administered by intravenous (IV) infusion on Day 1 of each cycle.

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

Analysis denominator · Participants

Group	Source count
Rituximab 375 mg/m^2	338

Reported measurements

Cycle 2 (n=338)

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab 375 mg/m^2	50.5	24	Not reported	Not reported	Not reported

Cycle 6 (n=240)

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab 375 mg/m^2	68.3	4	Not reported	Not reported	Not reported

Cycle 8 (n=32)

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Rituximab 375 mg/m^2	87.5	0	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
24
value
50.5
title
Cycle 2 (n=338)
categories
measurements
group Id
OG000
spread
4
value
68.3
title
Cycle 6 (n=240)
categories
measurements
group Id
OG000
spread
0
value
87.5
title
Cycle 8 (n=32)

denoms

counts
group Id
OG000
value
338
units
Participants

description

groups

description
Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin \[doxorubicin\], Oncovin \[vincristine\], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m\^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
id
OG000
title
Rituximab 375 mg/m^2

param Type

NUMBER

population Description

Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1. Only patients with pre-dose CD19+ lymphocyte counts at each time point were included in the analyses.

reporting Status

POSTED

time Frame

Day 1 of Cycle 2 and either Cycle 6 or 8 (last cycle)

title

Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle)

type

SECONDARY

unit Of Measure

Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice