NCT00075725 · OUTCOME

Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).

Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia · Source last updated 2021-04-27

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: 95% Confidence Interval
Time frame: 5 years

What was measured

Bone marrow MRD status is defined as negative with \< .01 detectable leukemia cells.

Analysis population: Patients on Arm/Group "Prednisone and High Dose Methotrexate (non randomly assigned)" are not included in the OM as there were no survivors for the 5 year duration. Cohort of MRD Negative patients some of whom have had EFS/OS events after 5 years or have minimum 5 years of follow-up.

Groups in this outcome

Dexamethasone and Capizzi Methotrexate Patients < 10 Years

Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).

Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)

Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).

Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old

Dexamethasone, High Dose Methotrexate (IM) < 10 Years

Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).

Prednisone, Capizzi Methotrexate <10 Years

Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.

Prednisone, Capizzi Methotrexate >= 10 Years

Prednisone and High Dose Methotrexate < 10 Yrs Old

Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.

Prednisone and High Dose Methotrexate >=10 Years

Dexamethasone, High Dose Methotrexate (IM) >= 10 Years

Prednisone, Capizzi Methotrexate (Down's Syndrome)

Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)

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
Dexamethasone and Capizzi Methotrexate Patients < 10 Years	185
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)	73
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old	198
Dexamethasone, High Dose Methotrexate (IM) < 10 Years	189
Prednisone, Capizzi Methotrexate <10 Years	195
Prednisone, Capizzi Methotrexate >= 10 Years	472
Prednisone and High Dose Methotrexate < 10 Yrs Old	191
Prednisone and High Dose Methotrexate >=10 Years	480
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years	209
Prednisone, Capizzi Methotrexate (Down's Syndrome)	25
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)	4

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Dexamethasone and Capizzi Methotrexate Patients < 10 Years	95.4	Not reported	91.3	99.4	Not reported
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)	92.9	Not reported	85.4	100	Not reported
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old	87.4	Not reported	82.5	92.4	Not reported
Dexamethasone, High Dose Methotrexate (IM) < 10 Years	98.1	Not reported	95.4	100	Not reported
Prednisone, Capizzi Methotrexate <10 Years	93.3	Not reported	88.6	98.0	Not reported
Prednisone, Capizzi Methotrexate >= 10 Years	90.2	Not reported	85.5	94.9	Not reported
Prednisone and High Dose Methotrexate < 10 Yrs Old	94.5	Not reported	90.0	98.9	Not reported
Prednisone and High Dose Methotrexate >=10 Years	90.5	Not reported	86.1	95.0	Not reported
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years	91.6	Not reported	87.5	95.8	Not reported
Prednisone, Capizzi Methotrexate (Down's Syndrome)	78.3	Not reported	61.0	95.7	Not reported
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)	25.0	Not reported	-17.4	67.4	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
91.3
upper Limit
99.4
value
95.4
group Id
OG001
lower Limit
85.4
upper Limit
100
value
92.9
group Id
OG002
lower Limit
82.5
upper Limit
92.4
value
87.4
group Id
OG003
lower Limit
95.4
upper Limit
100
value
98.1
group Id
OG004
lower Limit
88.6
upper Limit
98.0
value
93.3
group Id
OG005
lower Limit
85.5
upper Limit
94.9
value
90.2
group Id
OG006
lower Limit
90.0
upper Limit
98.9
value
94.5
group Id
OG007
lower Limit
86.1
upper Limit
95.0
value
90.5
group Id
OG008
lower Limit
87.5
upper Limit
95.8
value
91.6
group Id
OG009
lower Limit
61.0
upper Limit
95.7
value
78.3
group Id
OG010
lower Limit
-17.4
upper Limit
67.4
value
25.0

denoms

counts
group Id
OG000
value
185
group Id
OG001
value
73
group Id
OG002
value
198
group Id
OG003
value
189
group Id
OG004
value
195
group Id
OG005
value
472
group Id
OG006
value
191
group Id
OG007
value
480
group Id
OG008
value
209
group Id
OG009
value
25
group Id
OG010
value
4
units
Participants

description

Bone marrow MRD status is defined as negative with \< .01 detectable leukemia cells.

dispersion Type

95% Confidence Interval

groups

description
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
id
OG000
title
Dexamethasone and Capizzi Methotrexate Patients < 10 Years
description
Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
id
OG001
title
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
description
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
id
OG002
title
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
description
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
id
OG003
title
Dexamethasone, High Dose Methotrexate (IM) < 10 Years
description
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
id
OG004
title
Prednisone, Capizzi Methotrexate <10 Years
description
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
id
OG005
title
Prednisone, Capizzi Methotrexate >= 10 Years
description
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
id
OG006
title
Prednisone and High Dose Methotrexate < 10 Yrs Old
description
Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
id
OG007
title
Prednisone and High Dose Methotrexate >=10 Years
description
Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
id
OG008
title
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
description
Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
id
OG009
title
Prednisone, Capizzi Methotrexate (Down's Syndrome)
description
Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
id
OG010
title
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)

param Type

NUMBER

population Description

Patients on Arm/Group "Prednisone and High Dose Methotrexate (non randomly assigned)" are not included in the OM as there were no survivors for the 5 year duration. Cohort of MRD Negative patients some of whom have had EFS/OS events after 5 years or have minimum 5 years of follow-up.

reporting Status

POSTED

time Frame

5 years

title

Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice