NCT00103285 · OUTCOME

Event-free Survival (EFS) for SR-Low Patients

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 time 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: Only eligible patients are included in the analysis.

Groups in this outcome

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

SR-low ALL, Arm II-combination Chemotherapy

Patients receive experimental consolidation therapy (vincristine sulfate, mercaptopurine, MTX, leucovorin calcium and pegaspargase), experimental interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine, MTX and pegaspargase), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX), 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
SR-low ALL, Arm I-combination Chemotherapy	928
SR-low ALL, Arm II-combination Chemotherapy	929

Reported measurements

Source class 1

Values in Percent probability · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
SR-low ALL, Arm I-combination Chemotherapy	95.22	Not reported	93.6	96.9	Not reported
SR-low ALL, Arm II-combination Chemotherapy	93.96	Not reported	92.1	95.8	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
93.6
upper Limit
96.9
value
95.22
group Id
OG001
lower Limit
92.1
upper Limit
95.8
value
93.96

denoms

counts
group Id
OG000
value
928
group Id
OG001
value
929
units
Participants

description

Event Free Probability where EFS time 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
SR-low ALL, Arm I-combination Chemotherapy
description
Patients receive experimental consolidation therapy (vincristine sulfate, mercaptopurine, MTX, leucovorin calcium and pegaspargase), experimental interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine, MTX and pegaspargase), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX), 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
SR-low ALL, Arm II-combination Chemotherapy

param Type

NUMBER

population Description

Only eligible patients are included in the analysis.

reporting Status

POSTED

time Frame

6 years

title

Event-free Survival (EFS) for SR-Low Patients

type

PRIMARY

unit Of Measure

Percent probability

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Preserved source evidence · Not medical advice