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NCT01872819 · OUTCOME

Rate of Complete Response, Defined by Criteria of Cheson et al.

Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay · Source last updated 2018-07-11

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
Baseline up to 2 years

What was measured

Number of patients who achieved a Complete Response (CR) with Minimal Residual Disease (MRD), a Complete Response with incomplete hematologic recovery (CRi), or showed reduced blasts in their bone marrow by flow cytometry (Cytoreduction). Cheson et al. defines a CR as: Bone Marrow blasts \<5%, absence of circulating blasts and blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count \>1.0 x 10\^9/L, and platelet count \>100 x 10\^9/L. Cheson et al. defines a CRi as: all CR criteria except for residual neutropenia (\<1.0 x 10\^9/L) or thrombocytopenia (\<100 x 10\^9/L).

Analysis population: 14 patients received therapy. Out of 14 patients treated, 9 were evaluable (4 patients died prior to D14-21 marrow and 1 patient refused the D14-21 marrow).

Groups in this outcome

Treated Patients

Not reported

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

Analysis denominator · Participants

GroupSource count
Treated Patients9

Reported measurements

CR with MRD
Values in Patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treated Patients1Not reportedNot reportedNot reportedNot reported
CRi
Values in Patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treated Patients2Not reportedNot reportedNot reportedNot reported
Cytoreduction
Values in Patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treated Patients6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    CR with MRD
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    CRi
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Cytoreduction
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    units
    Participants
description
Number of patients who achieved a Complete Response (CR) with Minimal Residual Disease (MRD), a Complete Response with incomplete hematologic recovery (CRi), or showed reduced blasts in their bone marrow by flow cytometry (Cytoreduction). Cheson et al. defines a CR as: Bone Marrow blasts \<5%, absence of circulating blasts and blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count \>1.0 x 10\^9/L, and platelet count \>100 x 10\^9/L. Cheson et al. defines a CRi as: all CR criteria except for residual neutropenia (\<1.0 x 10\^9/L) or thrombocytopenia (\<100 x 10\^9/L).
groups
  1. id
    OG000
    title
    Treated Patients
param Type
NUMBER
population Description
14 patients received therapy. Out of 14 patients treated, 9 were evaluable (4 patients died prior to D14-21 marrow and 1 patient refused the D14-21 marrow).
reporting Status
POSTED
time Frame
Baseline up to 2 years
title
Rate of Complete Response, Defined by Criteria of Cheson et al.
type
SECONDARY
unit Of Measure
Patients

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

Preserved source evidence · Not medical advice