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NCT01831232 · OUTCOME

Progression Free Survival (PFS)

Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes · Source last updated 2017-11-17

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

Measure
NUMBER
Unit
percentage of patients with PFS
Interval / dispersion
95% Confidence Interval
Time frame
1 year after treatment with IAP

Analysis population: Patients who had a good complete remission (CR), CR with evidence of minimal residual disease (MRD), or complete remission with incomplete blood count recovery (CRi) following treatment. Cheson AML Response Criteria are used to assess response.Good CR is defined as \<5% blasts in marrow, no MRD and recovery of blood counts by day 35 after induction.

Groups in this outcome

Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)

Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. pravastatin sodium: Given PO idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)17

Reported measurements

Source class 1
Values in percentage of patients with PFS · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)52.6Not reported28.771.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28.7
        upper Limit
        71.9
        value
        52.6
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive pravastatin sodium PO QD on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. pravastatin sodium: Given PO idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies
    id
    OG000
    title
    Treatment (Pravastatin Sodium, Idarubicin, and Cytarabine)
param Type
NUMBER
population Description
Patients who had a good complete remission (CR), CR with evidence of minimal residual disease (MRD), or complete remission with incomplete blood count recovery (CRi) following treatment. Cheson AML Response Criteria are used to assess response.Good CR is defined as \<5% blasts in marrow, no MRD and recovery of blood counts by day 35 after induction.
reporting Status
POSTED
time Frame
1 year after treatment with IAP
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
percentage of patients with PFS

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

Preserved source evidence · Not medical advice