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NCT00425477 · OUTCOME

Clinical Response (Complete and Partial)

Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia · Source last updated 2018-10-05

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
assessed after 2 cycles, up to 2 years

What was measured

Response to treatment was assessed after two cycles, according to International Working Group (IWG) criteria.

Groups in this outcome

Bexarotene + GM-CSF

BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.

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

Analysis denominator · Participants

GroupSource count
Bexarotene + GM-CSF13

Reported measurements

PR (partial remission)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bexarotene + GM-CSF0Not reportedNot reportedNot reportedNot reported
HI (hematologic improvement)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bexarotene + GM-CSF4Not reportedNot reportedNot reportedNot reported
SD (stable disease)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bexarotene + GM-CSF4Not reportedNot reportedNot reportedNot reported
PD (progressive disease)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bexarotene + GM-CSF5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    PR (partial remission)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    HI (hematologic improvement)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    SD (stable disease)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    PD (progressive disease)
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Response to treatment was assessed after two cycles, according to International Working Group (IWG) criteria.
groups
  1. description
    BEX and GM-CSF were administered in 4 week cycles. BEX was given orally with food daily for 28 days at the FDA-approved dose for treatment of CTCL of 300 mg/m2 and GM-CSF was given at a daily dose of 125 µg/m2 subcutaneously for 28 days.
    id
    OG000
    title
    Bexarotene + GM-CSF
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
assessed after 2 cycles, up to 2 years
title
Clinical Response (Complete and Partial)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice