NCT00720109 · OUTCOME

Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation

Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia · Source last updated 2020-04-13

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: 90% Confidence Interval
Time frame: At end of consolidation (at 11 weeks)

What was measured

A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used.

Analysis population: Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).

Groups in this outcome

Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)

See Detailed Description Asparaginase: Given IT Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dasatinib: Given PO Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Hydrocortisone Sodium Succinate: Given IT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV or PO Mercaptopurine: Given PO Methotrexate: Given IT, PO, or IV Methylprednisolone: Given IV Pegaspargase: Given IM Prednisone: Given PO or IV Radiation Therapy: Some patients undergo cranial RT Vincristine Sulfate: Given IV

Standard-risk

Based on Minimal Residual Disease, less than 1%.

High-risk

Based on Minimal Residual Disease, great than or equal to 1%.

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
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)	57
Standard-risk	48
High-risk	9

Reported measurements

Source class 1

Values in Percentage of participants · Interval/dispersion: 90% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)	10.5	Not reported	5.3	19.3	Not reported
Standard-risk	0	Not reported	0.0	6.4	Not reported
High-risk	66.7	Not reported	39.6	96.1	Not reported

Source statistical analyses

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

ci Lower Limit
5.3
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
19.3
estimate Comment
The pre-specified threshold for the estimated percentage of MRD positivity at End Consolidation was set to 16%. Results show an upper bound on the (Agresti-Coull) confidence interval of 19.3%.
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
=0.13
param Type
percentage
param Value
10.5
statistical Method
Binomial Test

Complete source fields

analyses

ci Lower Limit
5.3
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
19.3
estimate Comment
The pre-specified threshold for the estimated percentage of MRD positivity at End Consolidation was set to 16%. Results show an upper bound on the (Agresti-Coull) confidence interval of 19.3%.
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
=0.13
param Type
percentage
param Value
10.5
statistical Method
Binomial Test

classes

categories
measurements
group Id
OG000
lower Limit
5.3
upper Limit
19.3
value
10.5
group Id
OG001
lower Limit
0.0
upper Limit
6.4
value
0
group Id
OG002
lower Limit
39.6
upper Limit
96.1
value
66.7

denoms

counts
group Id
OG000
value
57
group Id
OG001
value
48
group Id
OG002
value
9
units
Participants

description

A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used.

dispersion Type

90% Confidence Interval

groups

description
See Detailed Description Asparaginase: Given IT Cyclophosphamide: Given IV Cytarabine: Given IT or IV Dasatinib: Given PO Daunorubicin Hydrochloride: Given IV Dexamethasone: Given IV or PO Etoposide: Given IV Filgrastim: Given IV or SC Hydrocortisone Sodium Succinate: Given IT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Leucovorin Calcium: Given IV or PO Mercaptopurine: Given PO Methotrexate: Given IT, PO, or IV Methylprednisolone: Given IV Pegaspargase: Given IM Prednisone: Given PO or IV Radiation Therapy: Some patients undergo cranial RT Vincristine Sulfate: Given IV
id
OG000
title
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)
description
Based on Minimal Residual Disease, less than 1%.
id
OG001
title
Standard-risk
description
Based on Minimal Residual Disease, great than or equal to 1%.
id
OG002
title
High-risk

param Type

NUMBER

population Description

Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).

reporting Status

POSTED

time Frame

At end of consolidation (at 11 weeks)

title

Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation

type

SECONDARY

unit Of Measure

Percentage of participants

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

Preserved source evidence · Not medical advice