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NCT00290472 · OUTCOME

Objective Overall Response Rate

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Up to 6 years

What was measured

The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10655437#) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires \>=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.

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 Lymphoma32
Follicular Lymphoma39
Chronic Lymphocytic Leukemia18

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Aggressive B-cell Lymphoma28.1Not reportedNot reportedNot reportedNot reported
Follicular Lymphoma53.8Not reportedNot reportedNot reportedNot reported
Chronic Lymphocytic Leukemia11.1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        28.1
      2. group Id
        OG001
        value
        53.8
      3. group Id
        OG002
        value
        11.1
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      39
    3. group Id
      OG002
      value
      18
    units
    Participants
description
The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10655437#) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires \>=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.
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
NUMBER
reporting Status
POSTED
time Frame
Up to 6 years
title
Objective Overall Response Rate
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice