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NCT00946647 · OUTCOME

Overall Response Rate (ORR) Assessed by Best Overall Response: Participants With MDS/CMML Per Investigator (Phase Llb)

A Phase Ib/IIb, Open-label, Multi-center, Study of Oral Panobinostat Administered With 5-Azacitidine (in Adult Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML). · Source last updated 2020-08-04

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
48 months

What was measured

Best overall response as measured by complete remission (CR) or bone marrow CR (BM-CR) or partial remission (PR) or hematologic improvement (HI). Overall response patients achieved other than the composite CR by individual response category: CR, CRi, mCR or PR as defined by the International Working Group (IWG) response criteria.

Analysis population: Full analysis set (FAS): Consisted of all patients who were randomized to one of the two treatment arms.

Groups in this outcome

Panobinostat + 5-Azacytidine

In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15. In both phases, dose of 5-Azacytidine was 75 mg/m\^2, subcutaneously Daily for Day 1 to Day 7.

5-Azacytidine

The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis. Dose of 5-Azacytidine : 75 mg/m\^2 subcutaneously daily from Day 1 to Day 7.

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

Analysis denominator · Participants

GroupSource count
Panobinostat + 5-Azacytidine31
5-Azacytidine29

Reported measurements

Clinical response (CR, BM-CR, PR, HI)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat + 5-Azacytidine41.9Not reportedNot reportedNot reportedNot reported
5-Azacytidine41.4Not reportedNot reportedNot reportedNot reported
Complete remission (CR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat + 5-Azacytidine16.1Not reportedNot reportedNot reportedNot reported
5-Azacytidine6.9Not reportedNot reportedNot reportedNot reported
Bone marrow CR (BM-CR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat + 5-Azacytidine12.9Not reportedNot reportedNot reportedNot reported
5-Azacytidine3.4Not reportedNot reportedNot reportedNot reported
Partial remission (PR)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panobinostat + 5-Azacytidine0.0Not reportedNot reportedNot reportedNot reported
5-Azacytidine6.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        41.9
      2. group Id
        OG001
        value
        41.4
    title
    Clinical response (CR, BM-CR, PR, HI)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        16.1
      2. group Id
        OG001
        value
        6.9
    title
    Complete remission (CR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        12.9
      2. group Id
        OG001
        value
        3.4
    title
    Bone marrow CR (BM-CR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        6.9
    title
    Partial remission (PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      29
    units
    Participants
description
Best overall response as measured by complete remission (CR) or bone marrow CR (BM-CR) or partial remission (PR) or hematologic improvement (HI). Overall response patients achieved other than the composite CR by individual response category: CR, CRi, mCR or PR as defined by the International Working Group (IWG) response criteria.
groups
  1. description
    In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15. In both phases, dose of 5-Azacytidine was 75 mg/m\^2, subcutaneously Daily for Day 1 to Day 7.
    id
    OG000
    title
    Panobinostat + 5-Azacytidine
  2. description
    The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis. Dose of 5-Azacytidine : 75 mg/m\^2 subcutaneously daily from Day 1 to Day 7.
    id
    OG001
    title
    5-Azacytidine
param Type
NUMBER
population Description
Full analysis set (FAS): Consisted of all patients who were randomized to one of the two treatment arms.
reporting Status
POSTED
time Frame
48 months
title
Overall Response Rate (ORR) Assessed by Best Overall Response: Participants With MDS/CMML Per Investigator (Phase Llb)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice