Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00058240 · OUTCOME

Overall Response Rate (CR + PR) of Flavopiridol in Patients Evaluated Utilizing the Revised National Cancer Institute-sponsored Working Group Guidelines

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
patients
Interval / dispersion
Not reported
Time frame
Up to 2 years

What was measured

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Groups in this outcome

Dose Level 1, 2, 3, 4

Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles. Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 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 1, 2, 3, 452

Reported measurements

Source class 1
Values in patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1, 2, 3, 421Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        21
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    units
    Participants
description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
groups
  1. description
    Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles Dose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles. Dose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles
    id
    OG000
    title
    Dose Level 1, 2, 3, 4
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 2 years
title
Overall Response Rate (CR + PR) of Flavopiridol in Patients Evaluated Utilizing the Revised National Cancer Institute-sponsored Working Group Guidelines
type
SECONDARY
unit Of Measure
patients

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

Preserved source evidence · Not medical advice