Trial · NCT01190930

Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma

NCT01190930, Phase 3, Completed, Children's Oncology Group; results first posted 2020-06-23

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma. Trials, record NCT01190930. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01190930

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma
NCT number: NCT01190930
Status: Completed
Phases: Phase 3
Enrollment: 9,350 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Acute Lymphoblastic Leukemia, Adult B Lymphoblastic Lymphoma, Ann Arbor Stage I B Lymphoblastic Lymphoma, Ann Arbor Stage II B Lymphoblastic Lymphoma, Childhood B Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, Childhood B Lymphoblastic Lymphoma, Down Syndrome, Hypodiploid B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive
Interventions: Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Leucovorin Calcium, Mercaptopurine, Methotrexate, Pegaspargase, Quality-of-Life Assessment, Questionnaire Administration, Thioguanine, Vincristine Sulfate
First posted: 2010-08-30
Last updated: 2026-05-28
Results first posted: 2020-06-23

Source ClinicalTrials.gov

Registered outcomes49

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization	5.7 years	DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
Primary	DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization	5.7 years	DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
Primary	DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens	5.1 years	DFS is calculated as the time from randomization at the end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
Primary	DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care	5.1 years	DFS is calculated as the time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. The 5-year DFS and 95% confidence interval for these patients will be estimated.
Primary	Sample Collection of Central Path Review Slides in B-LLy Patients	Up to 1 month	Percent of B-LLy patients who had adequate/usable samples of samples collected will be reported.
Primary	Event Free Survival (EFS) for B-LLy Patients	5 years	EFS is calculated as the Time from study enrollment to first event (induction failure, relapse, second malignancy, remission death) or date of last contact. The 5-year EFS and 95% confidence interval for these patients will be estimated.
Primary	Overall Survival (OS) for B-LLy Patients	5 years	OS is calculated as the time from study enrollment to death or date of last contact. The 5-year OS and 95% confidence interval for these patients will be estimated.
Secondary	Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional	2 Months	Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
Secondary	Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional	1 year	Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
Secondary	Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional	1.7 years	Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.

1 to 10 of 49Source ClinicalTrials.gov

See all 49 registered outcomes

Outcomes49

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization	5.7 years	Average Risk (AR) B-ALL patients who were randomized and started maintenance	percent probability	NUMBER
PRIMARY	DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization	5.7 years	Average Risk (AR) B-ALL patients who were randomized and started maintenance	percent probability	NUMBER
PRIMARY	DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens	5.1 years		percent probability	NUMBER
PRIMARY	DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care	5.1 years		percent probability	NUMBER
PRIMARY	Sample Collection of Central Path Review Slides in B-LLy Patients	Up to 1 month	patients who had samples collected near diagnosis	percentage of patients	NUMBER
PRIMARY	Event Free Survival (EFS) for B-LLy Patients	5 years	Ineligible patients are excluded	percent probability	NUMBER
PRIMARY	Overall Survival (OS) for B-LLy Patients	5 years	Ineligible patients are excluded	percent probability	NUMBER
SECONDARY	Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional	2 Months	AR patients who had data collected	Z-Score	MEAN
SECONDARY	Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional	1 year	AR patients who had data collected	Z-Score	MEAN
SECONDARY	Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional	1.7 years	AR patients who had data collected	Z-Score	MEAN

1 to 10 of 49Source ClinicalTrials.gov

See all 49 outcomes

Results by group55

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization	B-ALL Average Risk: MTX 20 mg/m^2/Week Starting Dose	95.05	95% Confidence Interval 93.27 to 96.83	percent probability
Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization	B-ALL Average Risk: MTX 40 mg/m^2/Week Starting Dose	94.17	95% Confidence Interval 92.23 to 96.11	percent probability
DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization	B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks	94.10	95% Confidence Interval 92.16 to 96.04	percent probability
DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization	B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks	95.13	95% Confidence Interval 93.35 to 96.91	percent probability
DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens	B-ALL Low Risk Arm I (LR-M)	98.75	95% Confidence Interval 97.14 to 100.00	percent probability
DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens	B-ALL Low Risk Arm II (LR-C)	98.50	95% Confidence Interval 96.75 to 100.00	percent probability
DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care	Standard Risk With Down Syndrome	89.77	95% Confidence Interval 83.60 to 95.94	percent probability
Sample Collection of Central Path Review Slides in B-LLy Patients	B-LLy	89.7	95% Confidence Interval 80.2 to 99.3	percentage of patients
Event Free Survival (EFS) for B-LLy Patients	B-LLy	94.54	95% Confidence Interval 78.17 to 100.00	percent probability
Overall Survival (OS) for B-LLy Patients	B-LLy	93.97	95% Confidence Interval 76.88 to 100.00	percent probability

1 to 10 of 55Source ClinicalTrials.gov

See all 55 results by group

Participant flow90

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Induction	STARTED	B-ALL	9,298
Induction	STARTED	B-LLy	52
Induction	STARTED	B-ALL Average Risk	0
Induction	STARTED	Standard Risk With Down Syndrome	0
Induction	STARTED	B-ALL Low Risk Arm I (LR-M)	0
Induction	STARTED	B-ALL Low Risk Arm II (LR-C)	0
Induction	STARTED	B-ALL Average Risk-Arm A	0
Induction	STARTED	B-ALL Average Risk-Arm B	0
Induction	STARTED	B-ALL Average Risk-Arm C	0
Induction	STARTED	B-ALL Average Risk-Arm D	0

1 to 10 of 90Source ClinicalTrials.gov

See all 90 participant flow

Adverse events3,830

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	B-ALL	26	9,229	26
other	Anemia	Blood and lymphatic system disorders	B-LLy	0	48	0
other	Anemia	Blood and lymphatic system disorders	B-ALL Average Risk	19	3,122	21
other	Anemia	Blood and lymphatic system disorders	Standard Risk With Down Syndrome	2	224	2
other	Anemia	Blood and lymphatic system disorders	B-ALL Low Risk Arm I (LR-M)	2	301	2
other	Anemia	Blood and lymphatic system disorders	B-ALL Low Risk Arm II (LR-C)	3	302	3
other	Anemia	Blood and lymphatic system disorders	B-ALL Average Risk-Arm A	2	600	2
other	Anemia	Blood and lymphatic system disorders	B-ALL Average Risk-Arm B	2	586	2
other	Anemia	Blood and lymphatic system disorders	B-ALL Average Risk-Arm C	2	586	2
other	Anemia	Blood and lymphatic system disorders	B-ALL Average Risk-Arm D	3	592	3

1 to 10 of 3,830Source ClinicalTrials.gov

See all 3,830 adverse events

Adverse event totals30

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	B-ALL	125	9,229
Total, all-cause mortality	B-LLy	2	48
Total, all-cause mortality	B-ALL Average Risk	16	3,122
Total, all-cause mortality	Standard Risk With Down Syndrome	11	224
Total, all-cause mortality	B-ALL Low Risk Arm I (LR-M)	0	301
Total, all-cause mortality	B-ALL Low Risk Arm II (LR-C)	1	302
Total, all-cause mortality	B-ALL Average Risk-Arm A	7	600
Total, all-cause mortality	B-ALL Average Risk-Arm B	8	586
Total, all-cause mortality	B-ALL Average Risk-Arm C	6	586
Total, all-cause mortality	B-ALL Average Risk-Arm D	7	592

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse event totals

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33411585	DERIVED	PubMed
37890117	DERIVED	PubMed
39121442	DERIVED	PubMed
40315406	DERIVED	PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180886	COG NCTN Network Group Operations Center	Hawkins, Douglas S.	COG RESEARCH FOUNDATION, LLC	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013	NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01190930

GET https://conductscience.org/api/trials/v1/NCT01190930/registered?page=2

API reference For AI assistants