A Phase II Study of Tretinoin plus Arsenic Trioxide in Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Therapy

Protocol
11-040
Full Title
Phase II Study of Combined Tretinoin and Arsenic Trioxide for Patients with Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy
Phase
II
Purpose

Tretinoin and arsenic trioxide are both used to treat acute promyelocytic leukemia (APL). Tretinoin, which is a form of vitamin A, causes APL cells (which are immature white blood cells) to mature. Arsenic trioxide is used in patients whose APL returns after initial treatment.

The standard treatment for APL is tretinoin followed by standard chemotherapy, but the chemotherapy can raise the risk of infections, bleeding, heart damage, bone marrow damage, and a second leukemia years later. In this study, researchers want to see if giving both tretinoin and arsenic trioxide to newly diagnosed APL patients reduces the amount of standard chemotherapy needed and lowers the incidence of side effects.

The chemotherapy drug idarubicin will be given only to patients who have a high number of immature white blood cells in their bodies at the beginning of treatment or if the number of white blood cells rises during treatment.

Eligibility

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

  • Patients must be newly diagnosed with APL.
  • Patients may not have had prior treatment for APL, although they may have received tretinoin for up to a week before entering the study.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Jae Park at 212-639-4048.

Disease(s)
Leukemia
Leukemia: Acute Myelogenous Leukemia

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