Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy

Study Status

Open to Enrollment

Study Description

This is a clinical trial for patients with acute promyelocytic leukemia (APL). The purpose of the study is to determine the effect of 2 drugs on APL. The first drug, tertinoin is an approved medication that causes the leukemia cells in APL to mature. The second drug, arsenic trioxide, is an approved medication for APL that comes back after earlier treatment.

APL is most often treated with tretinoin and standard chemotherapy. However the chemotherapy drugs can cause infection and bleeding as well as damage the heart and normal blood marrow cells. This can lead to a second leukemia years later.

In this study, we are using tretinoin and sersenic trioxide together to reduce the amount of stand chemotherapy patients get and decrease side effects. Patients will receive standard chemotherapy with a drug called idarubicin only if they have a higher chance of the leukemia coming back or a higher risk of side effects.

Treatment is divided into 3 parts: induction, consolidation and maintenance.

Induction phase: The goal of the induction phase is to put your leukemia into remission. This treatment will take about 5 weeks.  You will begin treatment in the hospital. Depending on your condition you may be able to complete treatment as an outpatient.

  • Tretinoin twice daily by mouth for 35 days
  • Arsenic trioxide infusion over 1 to 4 hours for a total of 35 doses

Consolidation: 2-6 weeks from the time you go into remission, you will start the consolidation phase. The purpose of this phase is to keep the leukemia from coming back. You will have 4 consolidation treatments with tertinoin and arsenic trioxide given 2 to 4 weeks apart.

  • Tretinoin twice daily by mouth for 15 days
  •  Arsenic trioxide infusion over 1 to 4 hours for a total of 25 doses, given as an outpatient each weekday for 5 weeks.

Maintenance phase: Because people with a high number of leukemia cells in their blood at the start of therapy have a higher chance of the leukemia coming back, they will receive maintenance therapy. You will only receive maintenance therapy if you fall into this risk group. About 4-6 after finishing consolidation treatment, you will begin maintenance therapy.

  • Tretinoin by mouth twice daily for 15 days
  •  Arsenic trioxide infusion over 1 to 4 hours for a total of 10 doses (given as outpatient for 2 weeks)

This treatment will be repeated every 3 months for a total of 8 times. Maintenance therapy will last 2 years.

Disease Status and/or Stage

Newly Diagnosed Acute Promyelocytic Leukemia


Memorial Sloan-Kettering Cancer Center

Key Eligibility

  • Age 18 and older
  • Acute Promyelocytic Leukemia
  • Previously untreated
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Gail Roboz, MD


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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