NCT01190930 · OUTCOME

Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical

Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma · Source last updated 2026-05-28

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

Measure: MEAN
Unit: Z-Score
Interval / dispersion: Standard Deviation
Time frame: 2.4 Years

What was measured

Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.

Analysis population: AR patients who had data collected

Groups in this outcome

B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks

Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1

B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks

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
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks	111
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks	98

Reported measurements

Source class 1

Values in Z-Score · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks	-0.64	1.11	Not reported	Not reported	Not reported
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks	-0.67	1.19	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
1.11
value
-0.64
group Id
OG001
spread
1.19
value
-0.67

denoms

counts
group Id
OG000
value
111
group Id
OG001
value
98
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
id
OG000
title
B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks
description
Cons. (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34 Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1 Arm A: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm B: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1 Arm C: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1 Arm D: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
id
OG001
title
B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks

param Type

MEAN

population Description

AR patients who had data collected

reporting Status

POSTED

time Frame

2.4 Years

title

Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical

type

SECONDARY

unit Of Measure

Z-Score

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Preserved source evidence · Not medical advice