NCT00103285 · OUTCOME

Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative)

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia · Source last updated 2021-06-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Percent probability
Interval / dispersion: 95% Confidence Interval
Time frame: 6 years

What was measured

Event-free probability where EFS is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.

Analysis population: Patients on the two arms being compared got similar therapy. All patients included in this analysis are MRD negative. SR-Average patients who were CNS2 at diagnosis were excluded in order to have comparable patient cohorts. SR-Low patients are TEL/Trisomy positive while SR-Average patients are TEL/Trisomy negative.

Groups in this outcome

Group 1-SR-low ALL, Arm I-combination Chemotherapy

Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV

Group 2-SR-avg ALL, Arm I-combination Chemotherapy

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
Group 1-SR-low ALL, Arm I-combination Chemotherapy	926
Group 2-SR-avg ALL, Arm I-combination Chemotherapy	422

Reported measurements

Source class 1

Values in Percent probability · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Group 1-SR-low ALL, Arm I-combination Chemotherapy	95.22	Not reported	93.58	96.86	Not reported
Group 2-SR-avg ALL, Arm I-combination Chemotherapy	88.52	Not reported	84.56	92.48	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
93.58
upper Limit
96.86
value
95.22
group Id
OG001
lower Limit
84.56
upper Limit
92.48
value
88.52

denoms

counts
group Id
OG000
value
926
group Id
OG001
value
422
units
Participants

description

Event-free probability where EFS is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.

dispersion Type

95% Confidence Interval

groups

description
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV
id
OG000
title
Group 1-SR-low ALL, Arm I-combination Chemotherapy
description
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years. doxorubicin hydrochloride: Given IV or IT cytarabine: Given IV or SC dexamethasone: Given IV or PO pegaspargase: Given IM methotrexate: Given IM or IT leucovorin calcium: Given PO mercaptopurine: Given PO cyclophosphamide: Given IV thioguanine: Given PO vincristine sulfate: Given IV
id
OG001
title
Group 2-SR-avg ALL, Arm I-combination Chemotherapy

param Type

NUMBER

population Description

Patients on the two arms being compared got similar therapy. All patients included in this analysis are MRD negative. SR-Average patients who were CNS2 at diagnosis were excluded in order to have comparable patient cohorts. SR-Low patients are TEL/Trisomy positive while SR-Average patients are TEL/Trisomy negative.

reporting Status

POSTED

time Frame

6 years

title

Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative)

type

SECONDARY

unit Of Measure

Percent probability

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Preserved source evidence · Not medical advice