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

SUMMARY

You are being asked to take part in this research study because you have been diagnosed with acute promyelocytic leukemia (APL)

A clinical study has shown that a drug called arsenic trioxide, given with other standard chemotherapy drugs, works well in the treatment for APL in adults. Arsenic trioxide has also been evaluated in small groups of children with APL. These studies have determined a dose of arsenic trioxide that is well tolerated with other chemotherapy drugs.

The main goal of this study is to find out if completely removing or reducing the amount of anthracycline chemotherapy used in standard APL treatment, and adding arsenic trioxide, will reduce some of the long-term side effects while maintaining a good cure rate. This will include elimination of the maintenance phase of therapy and increasing the duration of the consolidation phase of therapy.

Other goals of this study are:

1. To understand the biology of APL better by doing specialized laboratory tests on bone marrow and blood.

2. To see if the use of arsenic trioxide affects functions of the brain such as learning.

APL is a type of cancer that occurs in the bone marrow, the spongy tissue inside the large bones of the body where blood cells are made. In APL, the bone marrow makes a large number of immature white blood cells that crowd out the normal cells of the bone marrow. These immature white blood cells may flood the bloodstream and invade vital organs. Any organ or organs may be affected including the brain, lungs, testes, ovaries, or skin. The APL cells can sometimes form a solid mass, which is called a chloroma.

COH Protocol Number : 15306

ClinicalTrials.gov Number : NCT02339740

Principal Investigator : Pawlowska, Anna M.D.

Sponsor : Children's Oncology Group (COG)

BRIEF ELIGIBILITY CRITERIA :

Eligible Ages : <=21;>=12

Gender : Either

Treatment Intent : Non-Adjuvant treatment

Prior Chemotherapy :

Brain Metastases :

Measurable Disease :