Acute Promyelocytic Leukemia Treatment using Arsenic Trioxide and All Trans-Retinoic Acid – Phase III

AAML1331: Study for Patients with Newly Diagnosed Acute Promyelocytic Leukemia using Arsenic Trioxide and All Trans-Retinoic Acid

Protocol Description

This multicenter trial by the Children’s Oncology Group, studies a combination of two drugs in treating patients with newly diagnosed acute promyelocytic leukemia (APL). Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth, and arsenic trioxide may stop cancer cell growth by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Researchers believe that these may provide a beneficial alternative to current standard chemotherapy for these conditions, which involves high doses of anthracyclines, which can have long-term side effects, especially to the heart.

Study Level: Phase III

Eligibility Criteria

Patients who have been newly diagnosed with APL up to age 21 and of either gender may be considered for this study, subject to certain exclusion criteria.
Males and Females: Up to 21 years of age


Patients enrolled in the study will be placed into a study group of either standard-risk or high-risk cases, as determined by blood tests. Participants will receive tretinoin and arsenic trioxide as part of their chemotherapy, and those in the high-risk group will also receive idarubicin and dexamethasone during the first stage of chemotherapy, which is induction therapy.
Visits: About the same as required by standard chemotherapy for these conditions.
Duration: 8 to 9 months

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (AAML1331)
National Cancer Institute

Primary Investigator

A. Kim Ritchey, MD

Contact Information

For more information about the study or enrollment, please contact:
A. Kim Ritchey, MD