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NCT00546377 · OUTCOME

Overall Response

Pentostatin, Cyclophosphamide, Rituximab, and Mitoxantrone in Treating Patients With Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Cancer · Source last updated 2016-05-12

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
3 years

What was measured

Complete response (CR): Absence of lymphadenopathy, hepatomegaly or splenomegaly by physical examination and appropriate radiographic techniques (if abnormal pre-treatment): it is recognized that some patients with lymphoid malignancies who achieve a CR may have mild persistent abnormalities on CT Scan. Such abnormalities if stable on subsequent scanning will not be viewed as persistent disease in patients who otherwise meet the criteria for CR. Response will be assessed on an ongoing basis, but at a minimum of prior to cycle four and following completion of all therapy. Patients who are removed from study early will have response status determined at time of removal from study. The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Radiographic studies are not required but those that were abnormal pre-treatment, will be repeated to document the degree of maximal response.

Groups in this outcome

Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone

To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.

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

Analysis denominator · Participants

GroupSource count
Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone43

Reported measurements

Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone11Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone23Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone4Not reportedNot reportedNot reportedNot reported
Progression of Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        23
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Stable Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Progression of Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    units
    Participants
description
Complete response (CR): Absence of lymphadenopathy, hepatomegaly or splenomegaly by physical examination and appropriate radiographic techniques (if abnormal pre-treatment): it is recognized that some patients with lymphoid malignancies who achieve a CR may have mild persistent abnormalities on CT Scan. Such abnormalities if stable on subsequent scanning will not be viewed as persistent disease in patients who otherwise meet the criteria for CR. Response will be assessed on an ongoing basis, but at a minimum of prior to cycle four and following completion of all therapy. Patients who are removed from study early will have response status determined at time of removal from study. The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Radiographic studies are not required but those that were abnormal pre-treatment, will be repeated to document the degree of maximal response.
groups
  1. description
    To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
    id
    OG000
    title
    Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone
param Type
NUMBER
reporting Status
POSTED
time Frame
3 years
title
Overall Response
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice