Trial · NCT00866918

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia

NCT00866918, Phase 3, Completed, Children's Oncology Group; results first posted 2017-04-04

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia. Trials, record NCT00866918. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00866918

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Trial

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

Title: Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia
NCT number: NCT00866918
Status: Completed
Phases: Phase 3
Enrollment: 106 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Childhood Acute Promyelocytic Leukemia With PML-RARA, Myeloid Neoplasm
Interventions: Arsenic Trioxide, Cytarabine, Diagnostic Laboratory Biomarker Analysis, Idarubicin, Mercaptopurine, Methotrexate, Mitoxantrone Hydrochloride, Tretinoin
First posted: 2009-03-23
Last updated: 2022-10-25
Results first posted: 2017-04-04

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Event-free Survival (EFS)	At 3 years from study entry	EFS - time from study entry until failure to achieve complete remission during consolidation, relapse, or death. For further clarification see definitions provided in the protocol.
Secondary	Hematologic Remission Rate	End of consolidation, course 1: up to 5 months	Proportion of patients in hematologic remission at end of consolidation, course 1 are reported.
Secondary	Hematologic, Molecular, and Cytogenetic Remission Rate	End of consolidation, course 3; up to 7 months (for Standard Risk) or end of consolidation, course 4; up to 9 months (for High Risk)	Proportion of patients in hematologic, molecular, and cytogenetic remission at end of consolidation, course 3 and 4 are reported. Patients were determined to be in remission by all three criteria.
Secondary	Overall Survival (OS)	At 3 years from study entry	OS - time from study entry to death.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event-free Survival (EFS)	At 3 years from study entry	Ineligible and inevaluable patients are excluded from analyses of EFS.	Percentage of participants	NUMBER
SECONDARY	Hematologic Remission Rate	End of consolidation, course 1: up to 5 months	Patients who were ineligible (n=6), inevaluable (n=1), or who electively withdrew during Induction (n=4) were excluded.	Proportion of participants	NUMBER
SECONDARY	Hematologic, Molecular, and Cytogenetic Remission Rate	End of consolidation, course 3; up to 7 months (for Standard Risk) or end of consolidation, course 4; up to 9 months (for High Risk)	Patients who were ineligible (n=6), inevaluable (n=1), or who electively withdrew during Induction (n=4) were excluded.	Proportion of participants	NUMBER
SECONDARY	Overall Survival (OS)	At 3 years from study entry	Ineligible and inevaluable patients are excluded from analyses of OS.	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Event-free Survival (EFS)	Standard Risk	95.4	95% Confidence Interval 86.3 to 98.5	Percentage of participants
Event-free Survival (EFS)	High Risk	82.9	95% Confidence Interval 65.8 to 91.9	Percentage of participants
Hematologic Remission Rate	Standard Risk	1.0000		Proportion of participants
Hematologic Remission Rate	High Risk	0.8824		Proportion of participants
Hematologic, Molecular, and Cytogenetic Remission Rate	Standard Risk	0.8095		Proportion of participants
Hematologic, Molecular, and Cytogenetic Remission Rate	High Risk	0.5882		Proportion of participants
Overall Survival (OS)	Standard Risk	98.4	95% Confidence Interval 89.6 to 99.8	Percentage of participants
Overall Survival (OS)	High Risk	85.7	95% Confidence Interval 69.0 to 93.8	Percentage of participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Standard Risk	69
Overall Study	STARTED	High Risk	39
Overall Study	COMPLETED	Standard Risk	53
Overall Study	COMPLETED	High Risk	27
Overall Study	NOT COMPLETED	Standard Risk	16
Overall Study	NOT COMPLETED	High Risk	12

Source ClinicalTrials.gov

Adverse events374

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
other	Abdominal pain	Gastrointestinal disorders	Standard Risk	3	66
other	Abdominal pain	Gastrointestinal disorders	High Risk	4	35
other	Acidosis	Metabolism and nutrition disorders	Standard Risk	0	66
other	Acidosis	Metabolism and nutrition disorders	High Risk	1	35
other	Activated partial thromboplastin time prolonged	Investigations	Standard Risk	2	66
other	Activated partial thromboplastin time prolonged	Investigations	High Risk	2	35
other	Acute kidney injury	Renal and urinary disorders	Standard Risk	1	66
other	Acute kidney injury	Renal and urinary disorders	High Risk	2	35
other	Adult respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Standard Risk	2	66
other	Adult respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	High Risk	1	35

1 to 10 of 374Source ClinicalTrials.gov

See all 374 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard Risk
Total, all-cause mortality	High Risk
Total, other adverse events	Standard Risk	61	66
Total, other adverse events	High Risk	33	35
Total, serious adverse events	Standard Risk	17	66
Total, serious adverse events	High Risk	14	35

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013

Source NIH RePORTER

Trial comparisons1

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

Comparison
Standard Risk vs High Risk: serious adverse events

Source Trial comparisons

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/NCT00866918

GET https://conductscience.org/api/trials/v1/NCT00866918/events?page=2

API reference For AI assistants