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NCT00288067 · OUTCOME

Response Rates of B-Non-Hodgkin Lymphoma to the Combination of Rituximab and Fenretinide (Phase II)

Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma · Source last updated 2014-10-06

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 7 years

What was measured

The trial was stratified into rituximab-naïve and rituximab pre-treated patients, and the target response rates for these groups were expected to be 30% and 10%, respectively. The numbers reported below are subjects who achieved a response of partial response or better.

Analysis population: No subjects in Phase 1 met the DLT, therefore Phase II was conducted at 900mg/m2. Of the 32 subjects, 4 subjects were not evaluable for disease response (2 subjects in Phase 1 and 2 subjects in Phase 2).

Groups in this outcome

Fenretinide and Rituximab (Rituximab Naive)

PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.

Fenretinide and Rituximab (Rituximab Pre Treated)

PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.

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

Analysis denominator · Participants

GroupSource count
Fenretinide and Rituximab (Rituximab Naive)7
Fenretinide and Rituximab (Rituximab Pre Treated)16

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fenretinide and Rituximab (Rituximab Naive)4Not reportedNot reportedNot reportedNot reported
Fenretinide and Rituximab (Rituximab Pre Treated)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      16
    units
    Participants
description
The trial was stratified into rituximab-naïve and rituximab pre-treated patients, and the target response rates for these groups were expected to be 30% and 10%, respectively. The numbers reported below are subjects who achieved a response of partial response or better.
groups
  1. description
    PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.
    id
    OG000
    title
    Fenretinide and Rituximab (Rituximab Naive)
  2. description
    PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.
    id
    OG001
    title
    Fenretinide and Rituximab (Rituximab Pre Treated)
param Type
NUMBER
population Description
No subjects in Phase 1 met the DLT, therefore Phase II was conducted at 900mg/m2. Of the 32 subjects, 4 subjects were not evaluable for disease response (2 subjects in Phase 1 and 2 subjects in Phase 2).
time Frame
Up to 7 years
title
Response Rates of B-Non-Hodgkin Lymphoma to the Combination of Rituximab and Fenretinide (Phase II)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice