NCT00136084 · OUTCOME

Minimal Residual Disease (MRD).

Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia · Source last updated 2012-12-05

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: Day 22 MRD measurement

What was measured

Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (\>=0.1%).

Analysis population: Of the 223 randomized patients, 205 patients were included in the day 22 MRD analysis. 18 patients were not included in the day 22 MRD analysis. 5 patients had inadequate sample for MRD, 11 patients had no suitable phenotype to determine MRD, 1 patient was not done on MRD, and 1 patient was lost for follow-up.

Groups in this outcome

Arm 1: (HDAC)

High-dose Cytarabine (HDAC)

Arm 2:(LDAC)

Low-dose Cytarabine (LDAC)

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

Analysis denominator · Participants

Group	Source count
Arm 1: (HDAC)	99
Arm 2:(LDAC)	106

Reported measurements

MRD Positive

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: (HDAC)	31	Not reported	Not reported	Not reported	Not reported
Arm 2:(LDAC)	43	Not reported	Not reported	Not reported	Not reported

MRD Negative

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm 1: (HDAC)	68	Not reported	Not reported	Not reported	Not reported
Arm 2:(LDAC)	63	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
.832
ci Pct Value
95
ci Upper Limit
3.205
estimate Comment
The odds ratio is defined as the ratio of the odds that a LDAC patient is MRD positive to the odds that a HDAC patient is MRD positive.
group Description
The study was designed to test the null hypothesis that HDAC and LDAC result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 186 MRD-evaluable patients in a 5-stage O'Brien-Fleming group sequential design gives 80% power at the 5% level to detect a change in the MRD-positive proportion from 0.50 to 0.30. The design was developed using East statistical software.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
.1559
p Value Comment
The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.041 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
1.624
statistical Comment
The p-value was computed using a Monte Carlo approximation (10000 permutations) to an exact, risk-group stratified, test.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
.832
ci Pct Value
95
ci Upper Limit
3.205
estimate Comment
The odds ratio is defined as the ratio of the odds that a LDAC patient is MRD positive to the odds that a HDAC patient is MRD positive.
group Description
The study was designed to test the null hypothesis that HDAC and LDAC result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 186 MRD-evaluable patients in a 5-stage O'Brien-Fleming group sequential design gives 80% power at the 5% level to detect a change in the MRD-positive proportion from 0.50 to 0.30. The design was developed using East statistical software.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
.1559
p Value Comment
The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.041 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
1.624
statistical Comment
The p-value was computed using a Monte Carlo approximation (10000 permutations) to an exact, risk-group stratified, test.
statistical Method
Cochran-Mantel-Haenszel
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
value
31
group Id
OG001
value
43
title
MRD Positive
categories
measurements
group Id
OG000
value
68
group Id
OG001
value
63
title
MRD Negative

denoms

counts
group Id
OG000
value
99
group Id
OG001
value
106
units
Participants

description

Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (\>=0.1%).

groups

description
High-dose Cytarabine (HDAC)
id
OG000
title
Arm 1: (HDAC)
description
Low-dose Cytarabine (LDAC)
id
OG001
title
Arm 2:(LDAC)

param Type

NUMBER

population Description

Of the 223 randomized patients, 205 patients were included in the day 22 MRD analysis. 18 patients were not included in the day 22 MRD analysis. 5 patients had inadequate sample for MRD, 11 patients had no suitable phenotype to determine MRD, 1 patient was not done on MRD, and 1 patient was lost for follow-up.

reporting Status

POSTED

time Frame

Day 22 MRD measurement

title

Minimal Residual Disease (MRD).

type

PRIMARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice