Research

Acute Promyelocytic Leukemia Treatment with Trisenox – Phase III

Risk-Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia using Arsenic Trioxide During Consolidation

Protocol Description

The primary goal of this Children’s Oncology Group Phase III study is to determine the effectiveness of a particular combination chemotherapy in treating young patients with newly diagnosed acute promyelocytic leukemia (APL). The therapy being tested uses less anthracycline than standard care, but adds arsenic trioxide, known by the brand name Trisenox. Researchers hope to find an alternative to use of high doses of anthracycine, because of long-term negative side effects of the drug.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders, from ages 2 to 21, who have newly diagnosed APL.
Males: Ages 2 to 21 years
Females: Ages 2 to 21 years

Requirements
Researchers have established separate tracks for high-risk and standard-risk participants, each consisting of induction chemotherapy and at least 3 courses of consolidation chemotherapy of which one will include the drug Trisenox. High-risk participants will receive a fourth consolidation course. Maintenance chemotherapy follows.
Duration: About 2.5 years

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study AAML0631)
National Cancer Institute
Cephalon, Inc.

Additional Resources
Study Description at National Institutes of Health