Clinical Trial NU MSK11H01
- Phase II Study of Combined Tretinoin and Arsenic Trioxide for Patients with Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy
- Principal Investigator
- Jessica Altman
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.NU MSK11H01
- The purpose of this study is to find what effects treatment with two drugs has on the body and leukemia.
- Participants in this study have a blood cancer called acute promyelocytic leukemia (APL). In this disease, immature white blood cells, , build up in the bone marrow.. In this study, tretinoin and arsenic trioxide are being used together. Tretinoin is an approved medicine that causes the leukemia cells in APL to mature. It is related to vitamin A. The second is arsenic trioxide. Arsenic trioxide is an approved medicine for APL that comes back after earlier treatment.
Some of the eligibility criteria include:
- Participant must be at least 18 years of age.
- Participant has been diagnosed with acute promyelocytic leukemia (APL).
- Participant has not had previous treatment for APL, except for tretinoin.
- Description of Treatment
- Treatment is divided into three parts, called induction, consolidation, and maintenance. The goal of first part of treatment, called induction, is to put the leukemia into remission. Participants will receive Tretinoin twice daily by mouth for 35 days. Arsenic trioxide will be given by vein over 1 to 4 hours for a total of 35 doses. The next part of the study is called consolidation. The purpose of consolidation is to keep the leukemia from coming back. Participants will have four consolidation treatments with tretinoin and arsenic trioxide given 2 to 4 weeks apart. Each will consist of tretinoin given twice daily by mouth for 15 days and arsenic trioxide given by vein over 1 to 4 hours for a total of 25 doses. Lastly, because people who have 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. Participants will be told if they have this risk at the beginning of the study. Participants who fall into this group will begin maintenance therapy. This will consist of Tretinoin by mouth twice daily for 15 days and arsenic trioxide given by vein over 1 to 4 hours for a total of 10 doses. Maintenance therapy will last two years.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase I, Open, Cohort Dose Escalation Trial with BI 836858 in Patients with Refractory or Relapsed Acute Myeloid Leukemia
- A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-881 in Patients with Advanced Hematologic Malignancies with an IDH1 and/or IDH2 Mutation
last updated: 17-Jan-17 11:51 PM
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