NCT00295932 · OUTCOME

Maximum Tolerated Dose

Bortezomib, Rituximab, Cyclophosphamide, and Prednisone in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma · Source last updated 2018-11-20

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

Measure: NUMBER
Unit: mg/m^2 of Bortezomib
Interval / dispersion: Not reported
Time frame: 2 years

What was measured

Maximum tolerated dose of Bortezomib in combination with Rituximab, Cyclophosphamide and Prednisone in Phase I participants

Analysis population: This outcome is only applicable for Phase I portion of the study. The purpose of the Phase I portion of the study is to determine the Maximum Tolerated Dose and for this reason the results are not separated by dose level.

Groups in this outcome

Arm I

Patients receive cyclophosphamide IV and rituximab IV on day 1, oral prednisone on days 2-6, and bortezomib IV (at the MTD determined in phase I) on days 2, 5, 9, and 12. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. rituximab: Given IV bortezomib: Given IV cyclophosphamide: Given IV prednisone: Given orally

Arm II

Patients receive cyclophosphamide IV and rituximab IV on day 1, oral prednisone on days 2-6, and bortezomib IV (at the MTD determined in phase I) on days 2 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. rituximab: Given IV bortezomib: Given IV cyclophosphamide: Given IV prednisone: Given orally

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
Arm I	54
Arm II	0

Reported measurements

Weekly Bortezomib

Values in mg/m^2 of Bortezomib · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	1.8	Not reported	Not reported	Not reported	Not reported

Twice-Weekly Bortezomib

Values in mg/m^2 of Bortezomib · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I	1.5	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1.8
title
Weekly Bortezomib
categories
measurements
group Id
OG000
value
1.5
title
Twice-Weekly Bortezomib

denoms

counts
group Id
OG000
value
54
group Id
OG001
value
0
units
Participants

description

Maximum tolerated dose of Bortezomib in combination with Rituximab, Cyclophosphamide and Prednisone in Phase I participants

groups

description
Patients receive cyclophosphamide IV and rituximab IV on day 1, oral prednisone on days 2-6, and bortezomib IV (at the MTD determined in phase I) on days 2, 5, 9, and 12. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. rituximab: Given IV bortezomib: Given IV cyclophosphamide: Given IV prednisone: Given orally
id
OG000
title
Arm I
description
Patients receive cyclophosphamide IV and rituximab IV on day 1, oral prednisone on days 2-6, and bortezomib IV (at the MTD determined in phase I) on days 2 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. rituximab: Given IV bortezomib: Given IV cyclophosphamide: Given IV prednisone: Given orally
id
OG001
title
Arm II

param Type

NUMBER

population Description

This outcome is only applicable for Phase I portion of the study. The purpose of the Phase I portion of the study is to determine the Maximum Tolerated Dose and for this reason the results are not separated by dose level.

reporting Status

POSTED

time Frame

2 years

title

Maximum Tolerated Dose

type

PRIMARY

unit Of Measure

mg/m^2 of Bortezomib

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

Preserved source evidence · Not medical advice