NCT01200758 · OUTCOME

Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab

A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma · Source last updated 2018-11-27

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

Measure: GEOMETRIC_MEAN
Unit: micrograms per milliliter (mcg/mL)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks)

Analysis population: Stage I pharmacokinetic (PK) evaluable population comprised all participants with data for Ctrough available at Cycle 7 and/or observed area under the serum concentration-time curve (AUC) available at Cycle 7. Participants were analyzed as per treatment received. Number of participants analyzed = participants analyzed for this outcome measure.

Groups in this outcome

Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)

Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.

Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)

First cycle of rituximab IV (375 mg/m\^2) + 7 cycles of rituximab subcutaneously (SC) (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.

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
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)	48
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)	54

Reported measurements

Source class 1

Values in micrograms per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)	83.1	36.7	Not reported	Not reported	Not reported
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)	134.6	43.2	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
1.36
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.94
estimate Comment
Geometric mean ratio adjusted for tumor load at baseline.
group Ids
OG000
OG001
non Inferiority Comment
Non-inferior Ctrough in SC formulation was demonstrated, if the lower bound of 90% confidence interval (CI) was above 0.8.
non Inferiority Type
NON_INFERIORITY_OR_EQUIVALENCE
param Type
Geometric mean ratio
param Value
1.62

Complete source fields

analyses

ci Lower Limit
1.36
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.94
estimate Comment
Geometric mean ratio adjusted for tumor load at baseline.
group Ids
OG000
OG001
non Inferiority Comment
Non-inferior Ctrough in SC formulation was demonstrated, if the lower bound of 90% confidence interval (CI) was above 0.8.
non Inferiority Type
NON_INFERIORITY_OR_EQUIVALENCE
param Type
Geometric mean ratio
param Value
1.62

classes

categories
measurements
group Id
OG000
spread
36.7
value
83.1
group Id
OG001
spread
43.2
value
134.6

denoms

counts
group Id
OG000
value
48
group Id
OG001
value
54
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.
id
OG000
title
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)
description
First cycle of rituximab IV (375 mg/m\^2) + 7 cycles of rituximab subcutaneously (SC) (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
id
OG001
title
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)

param Type

GEOMETRIC_MEAN

population Description

Stage I pharmacokinetic (PK) evaluable population comprised all participants with data for Ctrough available at Cycle 7 and/or observed area under the serum concentration-time curve (AUC) available at Cycle 7. Participants were analyzed as per treatment received. Number of participants analyzed = participants analyzed for this outcome measure.

reporting Status

POSTED

time Frame

Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks)

title

Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab

type

PRIMARY

unit Of Measure

micrograms per milliliter (mcg/mL)

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

Preserved source evidence · Not medical advice