Clinical trialNCT02339740Active, not recruitingPhase 3Interventional

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

SponsorChildren's Oncology GroupEnrollment158Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Matthew A Kutny
Children's Oncology Group
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

174 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

John Hunter Children'S Hospital
Hunter Regional Mail Centre, New South Wales, Australia
Sydney Children'S Hospital
Randwick, New South Wales, Australia
the Children'S Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Children'S Hospital
South Brisbane, Queensland, Australia
Women'S and Children'S Hospital-Adelaide
North Adelaide, South Australia, Australia
Royal Children'S Hospital
Parkville, Victoria, Australia
Perth Children'S Hospital
Perth, Western Australia, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia

Canada

Cancercare Manitoba
Winnipeg, Manitoba, Canada
Iwk Health Centre
Halifax, Nova Scotia, Canada
Mcmaster Children'S Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Children'S Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
the Montreal Children'S Hospital of the Muhc
Montreal, Quebec, Canada
Chu de Quebec-Centre Hospitalier de L'Universite Laval (chul)
Québec, Canada

New Zealand

Starship Children'S Hospital
Grafton, Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand

Puerto Rico

Hima San Pablo Oncologic Hospital
Caguas, Puerto Rico
San Jorge Children'S Hospital
San Juan, Puerto Rico
University Pediatric Hospital
San Juan, Puerto Rico

Saudi Arabia

King Faisal Specialist Hospital and Research Centre
Riyadh, Saudi Arabia

United States

Children'S Hospital of Alabama
Birmingham, Alabama, United States
Usa Health Strada Patient Care Center
Mobile, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Banner Children'S at Desert
Mesa, Arizona, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Arkansas Children'S Hospital
Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Children'S Hospital Los Angeles
Los Angeles, California, United States
Valley Children'S Hospital
Madera, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Ucsf Benioff Children'S Hospital Oakland
Oakland, California, United States
Children'S Hospital of Orange County
Orange, California, United States
Lucile Packard Children'S Hospital Stanford University
Palo Alto, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Naval Medical Center -San Diego
San Diego, California, United States

134 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Arsenic trioxide →Cytarabine →Dexamethasone →Idarubicin →Mitoxantrone →Tretinoin →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 21 Jul 2015
Primary completion: 31 Oct 2020
Completion: 30 Jun 2029
Last update posted: 18 Feb 2026
Registered enrollment: 158
Registry id: NCT02339740

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.