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AAML1331: A Phase III Study for Patients with Newly Diagnosed Acute Promyelocytic Leukemia (APL) using Arsenic Trioxide and All-Trans Retinoic Acid
Protocol Number:
Phase III
Cara Rabik
Johns Hopkins Kimmel Cancer Center in Baltimore
greater than 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. greater than Standard treatment for APL involves high doses of a common class of chemotherapy drugs called anthracyclines. High doses of anthracyclines are known to cause long-term side effects, especially to the heart. (Side effects are unintended and unwanted results of treatment.) Study doctors are interested in finding an effective treatment for APL that reduces the potential for long-term side effects. greater than 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. greater than 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.
Patients must be equal to 12 months and less than 22 years of age at first diagnosis of APL. Patients must be newly diagnosed with a clinical diagnosis of APL. Patients may receive up to a maximum of 5 days of pre-treatment with ATRA prior to administration of protocol therapy. Treatment with hydroxyurea, corticosteroids (any route) and intrathecal cytarabine prior to beginning protocol directed therapy is allowed. Patients with isolated myeloid sarcoma (myeloblastoma, chloroma, including leukemia cutis) but without evidence of APL by bone marrow or peripheral blood morphology are excluded.
In this Phase III trial, patients will be stratified into risk groups based on their presenting white blood cell (WBC) count ( less than 10,000/µL is standard risk and equal to 10,000/µL is high risk). All patients will receive daily ATRA and ATO during Induction. High risk patients will also receive 4 doses of idarubicin during Induction. Patients who are confirmed to have a hematologic complete remission at the end of Induction, will subsequently receive 28 weeks of Consolidation therapy with ATRA and ATO. Since there is no Maintenance therapy, the total duration of treatment will be reduced from approximately 30 months to approximately 8 months. Following 2 ATO cycles in Consolidation, patients will have a bone marrow evaluation to confirm molecular remission by real-time quantitative polymerase chain reaction (RQ-PCR) testing of PML-RARa. Based on the adult experience with this regimen, PCR positive disease at this Consolidation time point will be rare. The rare patients with PCR positive disease will receive an additional chemotherapy cycle (mitoxantrone, cytarabine and ATRA).
Last Update
03/05/2019 05:03 AM