A Phase II Study of Arsenic Trioxide and Tretinoin to Treat Children and Young Adults Newly Diagnosed with Acute Promyelocytic Leukemia

Full Title

A Phase III Study for Patients with Newly Diagnosed Acute Promyelocytic Leukemia (APL) using Arsenic Trioxide and All Trans-Retinoic Acid AAML1331 (CIRB)


The standard treatment of acute promyelocytic leukemia (APL) includes high doses of anticancer drugs called anthracyclines, which can cause long-term side effects such as heart problems. Doctors are interested in finding effective, less toxic treatments for APL in young patients.

Arsenic trioxide is a drug that works well against APL in adults. In this study, researchers are assessing treatment incorporating arsenic trioxide and tretinoin (a form of vitamin A), either in place of anthracyclines or used with lower doses of anthracyclines, in children and young adults with newly diagnosed APL. Some of the drugs in this study are taken orally (by mouth) while others are given intravenously (by vein).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have newly diagnosed APL that has not yet been treated with anticancer therapy.
  • This study is for patients ages 1 to 21 years.

For more information about this study and to inquire about eligibility, please contact Dr. Kavitha Ramaswamy at 212-639-8451.





Disease Status

Newly Diagnosed