NCT00720109 · OUTCOME

Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy

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 the end of induction therapy (at 5 weeks)

What was measured

Percent of patients MRD Positive (MRD \> 0.01%) at End of Induction.

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)	59
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)	40.7	Not reported	30.8	51.4	Not reported
Standard-risk	29.2	Not reported	19.7	40.9	Not reported
High-risk	100.0	Not reported	73.1	100.0	Not reported

Source statistical analyses

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

ci Lower Limit
30.8
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
51.4
group Description
The a priori plan was to compare MRD positivity rate with that on a prior study, AALL0031 (n=72 Cohorts 1-5 of AALL0031 with 71% MRD positive). Out of 59 patients with end-Induction MRD on AALL0622, 40.7% were MRD positive. Per protocol, rates will be compared with a 2 sample Z-test of proportions, 1-sided test, alpha=5%.
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
<0.001
param Type
Percentage
param Value
40.7
statistical Comment
Chi-squared test equivalent to Z-test of proportions.
statistical Method
Chi-squared

Complete source fields

analyses

ci Lower Limit
30.8
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
51.4
group Description
The a priori plan was to compare MRD positivity rate with that on a prior study, AALL0031 (n=72 Cohorts 1-5 of AALL0031 with 71% MRD positive). Out of 59 patients with end-Induction MRD on AALL0622, 40.7% were MRD positive. Per protocol, rates will be compared with a 2 sample Z-test of proportions, 1-sided test, alpha=5%.
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
<0.001
param Type
Percentage
param Value
40.7
statistical Comment
Chi-squared test equivalent to Z-test of proportions.
statistical Method
Chi-squared

classes

categories
measurements
group Id
OG000
lower Limit
30.8
upper Limit
51.4
value
40.7
group Id
OG001
lower Limit
19.7
upper Limit
40.9
value
29.2
group Id
OG002
lower Limit
73.1
upper Limit
100.0
value
100.0

denoms

counts
group Id
OG000
value
59
group Id
OG001
value
48
group Id
OG002
value
9
units
Participants

description

Percent of patients MRD Positive (MRD \> 0.01%) at End of Induction.

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 the end of induction therapy (at 5 weeks)

title

Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy

type

SECONDARY

unit Of Measure

Percentage of participants

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Preserved source evidence · Not medical advice