Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00703820 · OUTCOME

Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry

Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia · Source last updated 2021-08-10

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
Day 22 MRD measurement after one course of therapy

What was measured

MRD-negative is defined as \<0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as \>=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.

Analysis population: Of 262 randomized patients, 242 patients were included in day 22 MRD analysis. 20 patients were excluded due to: 16 were not evaluable by flow cytometry, 2 died prior to completing the first course of therapy, 2 were off therapy for unacceptable toxicity prior to completion of one course.

Groups in this outcome

Cytarabine+Daunorubicin+Etoposide

Patients received Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.

Clofarabine+Cytarabine

Patients received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.

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

Analysis denominator · Participants

GroupSource count
Cytarabine+Daunorubicin+Etoposide121
Clofarabine+Cytarabine121

Reported measurements

Source class 1

MRD Positive

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cytarabine+Daunorubicin+Etoposide42Not reportedNot reportedNot reportedNot reported
Clofarabine+Cytarabine57Not reportedNot reportedNot reportedNot reported

MRD Negative

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cytarabine+Daunorubicin+Etoposide79Not reportedNot reportedNot reportedNot reported
Clofarabine+Cytarabine64Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.03
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.41
    estimate Comment
    The odds ratio is defined as the ratio of the odds that a Clofarabine+Cytarabine patient is MRD positive to the odds that a Cytarabine+Daunorubicin+Etoposide patient is MRD positive.
    group Description
    The study was designed to test the null hypothesis that Cytarabine+Daunorubicin+Etoposide and Clofarabine+Cytarabine result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 240 MRD-evaluable patients in a 5-stage Haybittle-Peto group sequential design gives 80% power at the 5% level to detect an odds ratio of 2.5. The design was developed using East statistical software.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.035
    p Value Comment
    The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.0429 so that the overall level of the study is maintained at 0.05 across the 4 interim analyses and the final analysis.
    param Type
    Odds Ratio (OR)
    param Value
    1.87
    statistical Comment
    The p-value was computed using an exact, risk-group stratified, two-sided test.
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    1.03
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.41
    estimate Comment
    The odds ratio is defined as the ratio of the odds that a Clofarabine+Cytarabine patient is MRD positive to the odds that a Cytarabine+Daunorubicin+Etoposide patient is MRD positive.
    group Description
    The study was designed to test the null hypothesis that Cytarabine+Daunorubicin+Etoposide and Clofarabine+Cytarabine result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 240 MRD-evaluable patients in a 5-stage Haybittle-Peto group sequential design gives 80% power at the 5% level to detect an odds ratio of 2.5. The design was developed using East statistical software.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.035
    p Value Comment
    The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.0429 so that the overall level of the study is maintained at 0.05 across the 4 interim analyses and the final analysis.
    param Type
    Odds Ratio (OR)
    param Value
    1.87
    statistical Comment
    The p-value was computed using an exact, risk-group stratified, two-sided test.
    statistical Method
    Cochran-Mantel-Haenszel
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        57
      title
      MRD Positive
    2. measurements
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        64
      title
      MRD Negative
denoms
  1. counts
    1. group Id
      OG000
      value
      121
    2. group Id
      OG001
      value
      121
    units
    Participants
description
MRD-negative is defined as \<0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as \>=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.
groups
  1. description
    Patients received Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.
    id
    OG000
    title
    Cytarabine+Daunorubicin+Etoposide
  2. description
    Patients received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.
    id
    OG001
    title
    Clofarabine+Cytarabine
param Type
COUNT_OF_PARTICIPANTS
population Description
Of 262 randomized patients, 242 patients were included in day 22 MRD analysis. 20 patients were excluded due to: 16 were not evaluable by flow cytometry, 2 died prior to completing the first course of therapy, 2 were off therapy for unacceptable toxicity prior to completion of one course.
reporting Status
POSTED
time Frame
Day 22 MRD measurement after one course of therapy
title
Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice