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NCT00058240 · OUTCOME

Recommended Dose Level of Flavopiridol

Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma · Source last updated 2017-07-02

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

Measure
NUMBER
Unit
mg/m^2
Interval / dispersion
Not reported
Time frame
Up to 6 weeks

What was measured

Recommended dose determined by number of DLTs \[non-hematologic toxicity grade 3 or greater (excluding not life-threatening transient liver function or transient electrolyte abnormalities, fatigue, or diarrhea resolving within 4 days), some grade 2 toxicity (i.e. irreversible renal, chronic pulmonary, neurologic, or cardiac toxicity), hematologic toxicity of grade 4 thrombocytopenia/neutropenia persisting for 7 days or greater, or inability to continue cycle 2 by 7 weeks for reasons other than disease progression\] and consideration of number of patients with severe tumor lysis requiring hemodialysis with dose 1.

Groups in this outcome

Dose Level 4

Flavopiridol was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour beginning Dose Level 2 Cycle 1 for 6 Cycles.

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

Analysis denominator · Participants

GroupSource count
Dose Level 416

Reported measurements

Cycle 1 dose 1
Values in mg/m^2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 430Not reportedNot reportedNot reportedNot reported
Cycle 1 dose 2 thru Cycle 6
Values in mg/m^2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 450Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        30
    title
    Cycle 1 dose 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        50
    title
    Cycle 1 dose 2 thru Cycle 6
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
Recommended dose determined by number of DLTs \[non-hematologic toxicity grade 3 or greater (excluding not life-threatening transient liver function or transient electrolyte abnormalities, fatigue, or diarrhea resolving within 4 days), some grade 2 toxicity (i.e. irreversible renal, chronic pulmonary, neurologic, or cardiac toxicity), hematologic toxicity of grade 4 thrombocytopenia/neutropenia persisting for 7 days or greater, or inability to continue cycle 2 by 7 weeks for reasons other than disease progression\] and consideration of number of patients with severe tumor lysis requiring hemodialysis with dose 1.
groups
  1. description
    Flavopiridol was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour beginning Dose Level 2 Cycle 1 for 6 Cycles.
    id
    OG000
    title
    Dose Level 4
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 6 weeks
title
Recommended Dose Level of Flavopiridol
type
PRIMARY
unit Of Measure
mg/m^2

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

Preserved source evidence · Not medical advice