Clinical Trial

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

Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 25 amendments
This ClinicalTrials.gov record has been amended 25 times since 2015-01-14; most recent amendment 2026-02-04.
Status change: Completed → Active, Not Recruiting 2020-11-06
Status change: Active, Not Recruiting → Completed 2020-10-07
Status change: Recruiting → Active, Not Recruiting 2019-06-26
Status change: Not Yet Recruiting → Recruiting 2015-06-29
Trial Details
NCT Number NCT02339740
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA
Enrollment 158 participants
Start Date 2015-07-21
Primary Completion 2020-10-31 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-18