Trial · NCT00866307

Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)

NCT00866307, Phase 1, Completed, Children's Oncology Group; results first posted 2016-12-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011). Trials, record NCT00866307. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00866307

On this page

Trial

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

Title: Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)
NCT number: NCT00866307
Status: Completed
Phases: Phase 1
Enrollment: 104 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Acute Lymphoblastic Leukemia, Adult B Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia
Interventions: Cyclophosphamide, Cytarabine, Daunorubicin Hydrochloride, Dexamethasone, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Mercaptopurine, Methotrexate, Pegaspargase, Prednisone, Prophylactic Cranial Irradiation, Thioguanine, Vincristine Sulfate
First posted: 2009-03-20
Last updated: 2021-04-27
Results first posted: 2016-12-07
Limitations and caveats: The COG SDC reviewed the NLM notification related to ct.gov AE/SAE reporting. The information in 'Additional Description' is accurate with respect to data supplied to ct.gov.COG plans to submit data AE/SAE data consistent with the text in this field.

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	AALL08P1 Safety Outcome	Consolidation through Delayed Intensification	Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol.
Primary	AALL08P1 Feasibility Outcome	Consolidation through Delayed Intensification	Percentage of Group B (High Risk-High) patients that tolerate at least 8 of the 12-14 total doses of pegaspargase during Consolidation, Interim Maintenance, and Delayed Intensification periods. Only Grp B analyzed since this is prespecified in protocol.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	AALL08P1 Safety Outcome	Consolidation through Delayed Intensification	Patients with High Risk-High (Group B) Acute Lymphoblastic Leukemia (ALL)	percentage of participants	NUMBER
PRIMARY	AALL08P1 Feasibility Outcome	Consolidation through Delayed Intensification	Patients with High Risk-high Acute Lymphoblastic Leukemia (ALL)	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
AALL08P1 Safety Outcome	Group B (High Risk-High)		50.0	90% Confidence Interval 35.6 to 64.4	percentage of participants
AALL08P1 Feasibility Outcome	Group B (High Risk-High)		53.3	90% Confidence Interval 38.7 to 67.4	percentage of participants

Source ClinicalTrials.gov

Participant flow18

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

Period	Milestone	Group	Participants
Induction	STARTED	Induction	104
Induction	STARTED	Group A (High Risk-Average)	0
Induction	STARTED	Group B (High Risk-High)	0
Induction	COMPLETED	Induction	84
Induction	COMPLETED	Group A (High Risk-Average)	0
Induction	COMPLETED	Group B (High Risk-High)	0
Induction	NOT COMPLETED	Induction	20
Induction	NOT COMPLETED	Group A (High Risk-Average)	0
Induction	NOT COMPLETED	Group B (High Risk-High)	0
Consolidation/Maintenance	STARTED	Induction	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events537

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	Abdominal infection	Infections and infestations	Induction	2	104	2
other	Abdominal infection	Infections and infestations	Group A (High Risk-Average)	2	54	2
other	Abdominal infection	Infections and infestations	Group B (High Risk-High)	0	30	0
other	Abdominal pain	Gastrointestinal disorders	Induction	11	104	12
other	Abdominal pain	Gastrointestinal disorders	Group A (High Risk-Average)	8	54	9
other	Abdominal pain	Gastrointestinal disorders	Group B (High Risk-High)	3	30	3
other	Abducens nerve disorder	Nervous system disorders	Induction	1	104	1
other	Abducens nerve disorder	Nervous system disorders	Group A (High Risk-Average)	1	54	1
other	Abducens nerve disorder	Nervous system disorders	Group B (High Risk-High)	0	30	0
other	Activated partial thromboplastin time prolonged	Investigations	Induction	2	104	3

1 to 10 of 537Source ClinicalTrials.gov

See all 537 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Induction
Total, all-cause mortality	Group A (High Risk-Average)
Total, all-cause mortality	Group B (High Risk-High)
Total, other adverse events	Induction	97	104
Total, other adverse events	Group A (High Risk-Average)	53	54
Total, other adverse events	Group B (High Risk-High)	30	30
Total, serious adverse events	Induction	10	104
Total, serious adverse events	Group A (High Risk-Average)	1	54
Total, serious adverse events	Group B (High Risk-High)	4	30

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants4

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
U10CA180899	Children's Oncology Group Statistics and Data Center	ALONZO, TODD A	UNIVERSITY OF SOUTHERN CALIFORNIA	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA098413	Children's Oncology Group Statistics and Data Center Grant	DEVIDAS, MEENAKSHI	UNIVERSITY OF FLORIDA	NATIONAL CANCER INSTITUTE	2003 to 2013	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/NCT00866307

GET https://conductscience.org/api/trials/v1/NCT00866307/events?page=2

API reference For AI assistants