NCT02339740|Active Not RecruitingPhase 3Results

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

A Phase III Study for Patients With Newly Diagnosed Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide and All-Trans Retinoic Acid

Children's Oncology Group ClinicalTrials.gov

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4 other identifiers

AAML1331NCI-2014-02266PAAML1331_A01PAMDREVW0U10CA180886

Study Type

interventional

Target

158

Locations

6 countries

Sites

174

Timeline

RegisteredJan 2015

StartedJul 2015

CompletionJun 2029

Brief Summary

This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Completely removing or reducing the amount of anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an effective treatment for acute promyelocytic leukemia and may reduce some of the long-term side effects.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

158

participants targeted

Target at P25-P50 for phase_3

Timeline

39mo left

Started Jul 2015

Longer than P75 for phase_3

Geographic Reach

6 countries

174 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

14 years study duration

Study Progress77%

Jul 2015Jun 2029

First Submitted

Initial submission to the registry

January 13, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2015

Completed

6 months until next milestone

Study Start

First participant enrolled

July 21, 2015

Completed

5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

December 16, 2021

Completed

7.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Expected

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

5.3 years

First QC Date

January 13, 2015

Results QC Date

November 17, 2021

Last Update Submit

February 4, 2026

Conditions

Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA

Outcome Measures

Primary Outcomes (2)

Event-free Survival (EFS) in Standard Risk Acute Promyelocytic Leukemia (APL) Patients
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.
Up to 24 months
EFS in High Risk APL Patients
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.
Up to 24 months

Other Outcomes (11)

Induction Death Rate for Patients With FLT3 Mutations and Wild Type FLT3
Up to 70 days
Disease Free Survival (DFS)
Up to 70 days
Incidence of Serious Early Coagulopathy Events, Defined as Grade 3 or Higher Hemorrhage or Thrombosis
Up to 29 days of induction therapy
+8 more other outcomes

Study Arms (1)

Treatment (tretinoin, arsenic trioxide, chemotherapy)

EXPERIMENTAL

See Detailed Description

Drug: Arsenic TrioxideDrug: CytarabineDrug: DexamethasoneDrug: IdarubicinOther: Laboratory Biomarker AnalysisDrug: Mitoxantrone HydrochlorideOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationDrug: Tretinoin

Interventions

DexamethasoneDRUG

Given PO or IV

Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, LenaDex, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex