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NCT00057811 · OUTCOME

Response Rate

Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma · Source last updated 2014-09-19

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

Measure
NUMBER
Unit
percentage of participants analyzed
Interval / dispersion
95% Confidence Interval
Time frame
Up to 5 years

What was measured

Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain \<5% blasts. CSF WBC must be \<5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain \<5% blasts. CSF WBC must be \<5/μL with no blasts or lymphomatous cells present..

Analysis population: Population analyzed includes eligible patients considered evaluable for response (with measurable disease at on study and adequate assessment of response).

Groups in this outcome

Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)

Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.

Group C (Chemotherapy, Monoclonal Antibody Therapy)

Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.

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

Analysis denominator · Participants

GroupSource count
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)32
Group C (Chemotherapy, Monoclonal Antibody Therapy)23

Reported measurements

Source class 1
Values in percentage of participants analyzed · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)88Not reported7196Not reported
Group C (Chemotherapy, Monoclonal Antibody Therapy)83Not reported6195Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        71
        upper Limit
        96
        value
        88
      2. group Id
        OG001
        lower Limit
        61
        upper Limit
        95
        value
        83
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      23
    units
    Participants
description
Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain \<5% blasts. CSF WBC must be \<5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain \<5% blasts. CSF WBC must be \<5/μL with no blasts or lymphomatous cells present..
dispersion Type
95% Confidence Interval
groups
  1. description
    Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
    id
    OG000
    title
    Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)
  2. description
    Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
    id
    OG001
    title
    Group C (Chemotherapy, Monoclonal Antibody Therapy)
param Type
NUMBER
population Description
Population analyzed includes eligible patients considered evaluable for response (with measurable disease at on study and adequate assessment of response).
reporting Status
POSTED
time Frame
Up to 5 years
title
Response Rate
type
PRIMARY
unit Of Measure
percentage of participants analyzed

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

Preserved source evidence · Not medical advice