NCT00103285 · OUTCOME

Event-free Survival (EFS) for SR-Average ALL 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

EFS for SR-Average with standard and Intensified Consolidation. 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 this population. Populations are based on enrollments for all four arms initially, and then only for Arms I and II (standard therapy) once Arms III and IV (intensified therapy) were closed to accrual.

Groups in this outcome

Group 2-SR-avg 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 II-combination Chemotherapy

Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and MTX. Patients with Down syndrome (DS) receive leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and 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 III-combination Chemotherapy

Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and MTX. Patients with DS receive leucovorin calcium), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX. 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 IV-combination Chemotherapy

Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and 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 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 2-SR-avg ALL, Arm I-combination Chemotherapy	500
Group 2-SR-avg ALL, Arm II-combination Chemotherapy	509
Group 2-SR-avg ALL, Arm III-combination Chemotherapy	245
Group 2-SR-avg ALL, Arm IV-combination Chemotherapy	246

Reported measurements

Standard and Intensified therapy

Analysis denominator · Participants

Group	Source count
Group 2-SR-avg ALL, Arm I-combination Chemotherapy	244
Group 2-SR-avg ALL, Arm II-combination Chemotherapy	249
Group 2-SR-avg ALL, Arm III-combination Chemotherapy	245
Group 2-SR-avg ALL, Arm IV-combination Chemotherapy	246

Values in percent probability · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Group 2-SR-avg ALL, Arm I-combination Chemotherapy	83.82	Not reported	78.86	88.78	Not reported
Group 2-SR-avg ALL, Arm II-combination Chemotherapy	88.89	Not reported	84.79	92.99	Not reported
Group 2-SR-avg ALL, Arm III-combination Chemotherapy	88.34	Not reported	83.99	92.69	Not reported
Group 2-SR-avg ALL, Arm IV-combination Chemotherapy	90.51	Not reported	86.55	94.47	Not reported

Standard therapy

Analysis denominator · Participants

Group	Source count
Group 2-SR-avg ALL, Arm I-combination Chemotherapy	500
Group 2-SR-avg ALL, Arm II-combination Chemotherapy	509
Group 2-SR-avg ALL, Arm III-combination Chemotherapy	0
Group 2-SR-avg ALL, Arm IV-combination Chemotherapy	0

Values in percent probability · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Group 2-SR-avg ALL, Arm I-combination Chemotherapy	87.41	Not reported	83.63	91.19	Not reported
Group 2-SR-avg ALL, Arm II-combination Chemotherapy	88.29	Not reported	84.76	91.82	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
78.86
upper Limit
88.78
value
83.82
group Id
OG001
lower Limit
84.79
upper Limit
92.99
value
88.89
group Id
OG002
lower Limit
83.99
upper Limit
92.69
value
88.34
group Id
OG003
lower Limit
86.55
upper Limit
94.47
value
90.51
denoms
counts
group Id
OG000
value
244
group Id
OG001
value
249
group Id
OG002
value
245
group Id
OG003
value
246
units
Participants
title
Standard and Intensified therapy
categories
measurements
group Id
OG000
lower Limit
83.63
upper Limit
91.19
value
87.41
group Id
OG001
lower Limit
84.76
upper Limit
91.82
value
88.29
denoms
counts
group Id
OG000
value
500
group Id
OG001
value
509
group Id
OG002
value
0
group Id
OG003
value
0
units
Participants
title
Standard therapy

denoms

counts
group Id
OG000
value
500
group Id
OG001
value
509
group Id
OG002
value
245
group Id
OG003
value
246
units
Participants

description

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 2-SR-avg ALL, Arm I-combination Chemotherapy
description
Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and MTX. Patients with Down syndrome (DS) receive leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and 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 II-combination Chemotherapy
description
Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and MTX. Patients with DS receive leucovorin calcium), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX. 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
OG002
title
Group 2-SR-avg ALL, Arm III-combination Chemotherapy
description
Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and 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
OG003
title
Group 2-SR-avg ALL, Arm IV-combination Chemotherapy

param Type

NUMBER

population Description

Only eligible patients are included in this population. Populations are based on enrollments for all four arms initially, and then only for Arms I and II (standard therapy) once Arms III and IV (intensified therapy) were closed to accrual.

reporting Status

POSTED

time Frame

6 years

title

Event-free Survival (EFS) for SR-Average ALL Patients

type

PRIMARY

unit Of Measure

percent probability

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Preserved source evidence · Not medical advice