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NCT00621244 · OUTCOME

Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase

A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies · Source last updated 2021-01-05

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
1.2 years

What was measured

Stage 2 did not open for enrollment.

Analysis population: Full Analysis Set. Response as per investigator assessment for a subset of patients with AML accrued in the expansion phase (IA) include complete response, progressive disease/failure, stable disease.

Groups in this outcome

Arm 1, Group X

panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.

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

Analysis denominator · Participants

GroupSource count
Arm 1, Group X19

Reported measurements

Complete response (CR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Group X1Not reportedNot reportedNot reportedNot reported
Progressive disease (PD)/failure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Group X5Not reportedNot reportedNot reportedNot reported
Stable disease (SD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Group X6Not reportedNot reportedNot reportedNot reported
Not evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Group X2Not reportedNot reportedNot reportedNot reported
Missing
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1, Group X5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Complete response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Progressive disease (PD)/failure
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Stable disease (SD)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Not evaluable
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Missing
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
Stage 2 did not open for enrollment.
groups
  1. description
    panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication.
    id
    OG000
    title
    Arm 1, Group X
param Type
NUMBER
population Description
Full Analysis Set. Response as per investigator assessment for a subset of patients with AML accrued in the expansion phase (IA) include complete response, progressive disease/failure, stable disease.
reporting Status
POSTED
time Frame
1.2 years
title
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice