Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00290472 · OUTCOME

Duration of Response

CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia · Source last updated 2014-05-23

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

Measure
MEDIAN
Unit
Month
Interval / dispersion
95% Confidence Interval
Time frame
Up to 6 years

What was measured

Duration of response was the time from date of response to date of progression and evaluated among participants with response. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as \>=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.

Groups in this outcome

Aggressive B-cell Lymphoma

Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.

Follicular Lymphoma

Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.

Chronic Lymphocytic Leukemia

Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.

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

Analysis denominator · Participants

GroupSource count
Aggressive B-cell Lymphoma9
Follicular Lymphoma21
Chronic Lymphocytic Leukemia2

Reported measurements

Source class 1
Values in Month · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Aggressive B-cell Lymphoma2.4Not reported2.128.4Not reported
Follicular Lymphoma13.3Not reported6.216.5Not reported
Chronic Lymphocytic LeukemiaNANot reportedNANAChronic Lymphocytic Leukemia group had no progression events.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.1
        upper Limit
        28.4
        value
        2.4
      2. group Id
        OG001
        lower Limit
        6.2
        upper Limit
        16.5
        value
        13.3
      3. comment
        Chronic Lymphocytic Leukemia group had no progression events.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      21
    3. group Id
      OG002
      value
      2
    units
    Participants
description
Duration of response was the time from date of response to date of progression and evaluated among participants with response. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as \>=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
    id
    OG000
    title
    Aggressive B-cell Lymphoma
  2. description
    Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
    id
    OG001
    title
    Follicular Lymphoma
  3. description
    Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
    id
    OG002
    title
    Chronic Lymphocytic Leukemia
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 6 years
title
Duration of Response
type
PRIMARY
unit Of Measure
Month

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

Preserved source evidence · Not medical advice