Trial · NCT02339740

Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia

NCT02339740, Phase 3, Active not recruiting, Children's Oncology Group; results first posted 2021-12-16

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia. Trials, record NCT02339740. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02339740

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Trial

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

Title: Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia
NCT number: NCT02339740
Status: Active not recruiting
Phases: Phase 3
Enrollment: 158 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA
Interventions: Arsenic Trioxide, Cytarabine, Dexamethasone, Idarubicin, Laboratory Biomarker Analysis, Mitoxantrone Hydrochloride, Quality-of-Life Assessment, Questionnaire Administration, Tretinoin
First posted: 2015-01-15
Last updated: 2026-02-18
Results first posted: 2021-12-16

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	Event-free Survival (EFS) in Standard Risk Acute Promyelocytic Leukemia (APL) Patients	Up to 24 months	EFS is defined as the time from on study to failure to achieve hematological complete response (CR) prior to start of consolidation, persistence of molecular positive disease after minimal residual disease (MRD) positive consolidation course, relapse (molecular, morphologic or extramedullary), or death. The Kaplan-Meier method will be used to estimate 2-year EFS along with 90% log-minus-log transformed confidence limits.
Primary	EFS in High Risk APL Patients	Up to 24 months	EFS is defined as the time from on study to failure to achieve hematological CR prior to start of consolidation, persistence of molecular positive disease after MRD positive consolidation course, relapse (molecular, morphologic or extramedullary), or death. The Kaplan-Meier method will be used to estimate 2-year EFS along with 90% log-minus-log transformed confidence limits.
Other	Induction Death Rate for Patients With FLT3 Mutations and Wild Type FLT3	Up to 70 days	A Fisher's exact test will be used to compare the induction death rate for patients with FLT3 mutations to patients with wild type FLT3.
Other	Disease Free Survival (DFS)	Up to 70 days	For patients in remission at the end of induction, the log-rank test will be used to test for differences in DFS for those with end of induction real-time quantitative polymerase chain reaction (RQ-PCR) of \< 1 normalized copy number (NCN) compared with those with end of Induction RQ-PCR \>= 1 NCN.
Other	Incidence of Serious Early Coagulopathy Events, Defined as Grade 3 or Higher Hemorrhage or Thrombosis	Up to 29 days of induction therapy	Will calculate the International Society of Thrombosis and Haemostasis (ISTH) disseminated intravascular coagulation (DIC) score and compare the sensitivity and specificity of ISTH with that of thrombomodulin using McNemar's test for paired data. To improve the predictive ability of the ISTH DIC score, will use a stepwise combination of biomarkers. Receiver operating characteristic (ROC) curve will be used to assess the accuracy in prediction of bleeding events during induction and the areas under the ROC curve will be compared.
Other	Change in CogState Scores, Defined as a Decline of 5 Units in Mean Scores Apparent at 2 Years Off Therapy	End of induction up to 2 years post-treatment	Actual CogState scores for each domain at each time point will be summarized and examined by descriptive statistics and scatter plots. Change in score for a domain from end of induction will be calculated and summarized by descriptive statistics. The mean change of score from end of induction to a later time-point will be estimated with its 95% confidence interval. Linear mixed models using scores from all time-points as outcome will also be used to estimate the change in scores between time-points with adjustment for within-patient correlation of the score by random effects for individual patients.
Other	Change in Parent-reported Executive Functioning Over Time, Defined as a Decline of 5 Units in Mean Scores Apparent at 2 Years Off Therapy	End of induction up to 2 years post-treatment	Measured by the Behavioral Regulation, Working Memory and Metacognition Indices of the Behavior Rating Inventory of Executive Function. Change in score for a domain from end of induction will be calculated and summarized by descriptive statistics. The mean change of score from end of induction to a later time-point will be estimated with its 95% confidence interval. Linear mixed models using scores from all time-points as outcome will be used to estimate change in scores between time-points with adjustment for within-patient correlation of the score by random effects for individual patients.
Other	Change in Intellectual Functioning, Defined by Declines on the Wechsler-derived Estimated Intelligence Quotient and Processing Speed Scores	End of treatment to 4 years post-treatment	One sample t-test on the change of score will be used to examine if there is significant decline in neurocognitive function from end of induction to 2 years off therapy. Linear mixed models using scores from all time-points as outcome will also be used to estimate the change in scores between time-points with adjustment for within-patient correlation of the score by random effects for individual patients.
Other	Change in Memory Functioning, Defined by Declines on the Children's Memory Scale Faces and Stories Memory Scores	End of treatment to 4 years post-treatment	One sample t-test on the change of score will be used to examine if there is significant decline in neurocognitive function from end of induction to 2 years off therapy. Linear mixed models using scores from all time-points as outcome will also be used to estimate the change in scores between time-points with adjustment for within-patient correlation of the score by random effects for individual patients.
Other	Change in Verbal Learning Functioning, Defined by Declines on the California Verbal Learning Test Total Score	End of treatment to 4 years post-treatment	One sample t-test on the change of score will be used to examine if there is significant decline in neurocognitive function from end of induction to 2 years off therapy. Linear mixed models using scores from all time-points as outcome will also be used to estimate the change in scores between time-points with adjustment for within-patient correlation of the score by random effects for individual patients.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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) in Standard Risk Acute Promyelocytic Leukemia (APL) Patients	Up to 24 months	Patients ineligible, did not start treatment, or RQPCR positive not confirmed are excluded from analyses of EFS	percentage of participants	NUMBER
PRIMARY	EFS in High Risk APL Patients	Up to 24 months	Patients ineligible, did not start treatment, or RQPCR positive not confirmed are excluded from analyses of EFS	percentage of participants	NUMBER
OTHER_PRE_SPECIFIED	Induction Death Rate for Patients With FLT3 Mutations and Wild Type FLT3	Up to 70 days
OTHER_PRE_SPECIFIED	Disease Free Survival (DFS)	Up to 70 days
OTHER_PRE_SPECIFIED	Incidence of Serious Early Coagulopathy Events, Defined as Grade 3 or Higher Hemorrhage or Thrombosis	Up to 29 days of induction therapy
OTHER_PRE_SPECIFIED	Change in CogState Scores, Defined as a Decline of 5 Units in Mean Scores Apparent at 2 Years Off Therapy	End of induction up to 2 years post-treatment
OTHER_PRE_SPECIFIED	Change in Parent-reported Executive Functioning Over Time, Defined as a Decline of 5 Units in Mean Scores Apparent at 2 Years Off Therapy	End of induction up to 2 years post-treatment
OTHER_PRE_SPECIFIED	Change in Intellectual Functioning, Defined by Declines on the Wechsler-derived Estimated Intelligence Quotient and Processing Speed Scores	End of treatment to 4 years post-treatment
OTHER_PRE_SPECIFIED	Change in Memory Functioning, Defined by Declines on the Children's Memory Scale Faces and Stories Memory Scores	End of treatment to 4 years post-treatment
OTHER_PRE_SPECIFIED	Change in Verbal Learning Functioning, Defined by Declines on the California Verbal Learning Test Total Score	End of treatment to 4 years post-treatment

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Event-free Survival (EFS) in Standard Risk Acute Promyelocytic Leukemia (APL) Patients	Standard Risk		97.9	90% Confidence Interval 93.4 to 99.3	percentage of participants
EFS in High Risk APL Patients	High Risk		96.1	90% Confidence Interval 88.2 to 98.8	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	101
Overall Study	STARTED	High Risk	57
Overall Study	COMPLETED	Standard Risk	92
Overall Study	COMPLETED	High Risk	53
Overall Study	NOT COMPLETED	Standard Risk	9
Overall Study	NOT COMPLETED	High Risk	4

Source ClinicalTrials.gov

Adverse events230

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	Anemia	Blood and lymphatic system disorders	Standard Risk	1	101
other	Anemia	Blood and lymphatic system disorders	High Risk	0	57
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Standard Risk	1	101
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	High Risk	2	57
other	Febrile neutropenia	Blood and lymphatic system disorders	Standard Risk	9	101
other	Febrile neutropenia	Blood and lymphatic system disorders	High Risk	3	57
other	Left ventricular systolic dysfunction	Cardiac disorders	Standard Risk	0	101
other	Left ventricular systolic dysfunction	Cardiac disorders	High Risk	1	57
other	Sinus tachycardia	Cardiac disorders	Standard Risk	0	101
other	Sinus tachycardia	Cardiac disorders	High Risk	1	57

1 to 10 of 230Source ClinicalTrials.gov

See all 230 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard Risk	1	101
Total, all-cause mortality	High Risk	0	57
Total, other adverse events	Standard Risk	89	101
Total, other adverse events	High Risk	50	57
Total, serious adverse events	Standard Risk	3	101
Total, serious adverse events	High Risk	2	57

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34762093	DERIVED

Source PubMed

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
U10CA180886	COG NCTN Network Group Operations Center	Hawkins, Douglas S.	COG RESEARCH FOUNDATION, LLC	NATIONAL CANCER INSTITUTE	2014 to 2026

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Standard Risk vs High Risk: deaths from any cause	Trial comparisons
Standard Risk vs High Risk: serious adverse events	Trial comparisons

Tests1

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

Test	Named as
Verbal Learning	Other outcome

Source ConductCognition

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone 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/NCT02339740

GET https://conductscience.org/api/trials/v1/NCT02339740/events?page=2

API reference For AI assistants