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NCT02339740 · ClinicalTrials.gov registry record · Phase 3
Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia
A Phase 3 study of Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 3
- Development phase
- 158
- Enrollment target
- 20
- Study locations
NCT02339740: Active Phase 3 study of Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA, sponsored by Children's Oncology Group.
NCT02339740 is a Phase 3 study of Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 158 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02339740, a Phase 3 study of Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 158 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Dexamethasone
- DRUG Cytarabine
- DRUG Idarubicin
- DRUG Arsenic Trioxide
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Loma Linda University Medical Center - Loma Linda
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- University of California Davis Comprehensive Cancer Center - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- Naval Medical Center -San Diego - San Diego
- UCSF Medical Center-Mission Bay - San Francisco
Alabama
- Children's Hospital of Alabama - Birmingham
- USA Health Strada Patient Care Center - Mobile
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2015-07-21 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 3 |
What the registry record for NCT02339740 still lists
NCT02339740 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02339740 names 20 study sites across 5 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT02339740 about?
NCT02339740 is a clinical study titled "Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia". 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-ter...
What is the current status of trial NCT02339740?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 158 participants. The study started on 2015-07-21. Estimated completion is 2029-06-30.
What conditions does trial NCT02339740 study?
This clinical trial studies the following conditions: Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA.
What interventions are being tested in trial NCT02339740?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Dexamethasone (DRUG), Cytarabine (DRUG), Idarubicin (DRUG), Arsenic Trioxide (DRUG).
Who is sponsoring clinical trial NCT02339740?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02339740 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02339740's enrollment target sits among peer trials
158 1503rd of 2000 higher than 496 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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