Tretinoin + Arsenic Trioxide for Acute Promyelocytic Leukemia
Trial Summary
What is the purpose of this trial?
This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Completely removing or reducing the amount of anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an effective treatment for acute promyelocytic leukemia and may reduce some of the long-term side effects.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you can continue taking hydroxyurea, corticosteroids, and intrathecal cytarabine before starting the trial treatment.
What data supports the effectiveness of the drug combination of Tretinoin and Arsenic Trioxide for treating Acute Promyelocytic Leukemia?
Is the combination of Tretinoin and Arsenic Trioxide safe for humans?
The combination of Tretinoin (all-trans retinoic acid) and Arsenic Trioxide has been studied for treating acute promyelocytic leukemia and is generally well tolerated. Common side effects include fatigue, rash, fluid retention, and changes in heart rhythm, but it is considered relatively safe at the doses used for this condition.45678
What makes the drug combination of Tretinoin and Arsenic Trioxide unique for treating acute promyelocytic leukemia?
This drug combination is unique because it uses both Tretinoin and Arsenic Trioxide together to target acute promyelocytic leukemia, aiming to reduce relapse rates by combining their different mechanisms: Tretinoin helps immature blood cells mature, while Arsenic Trioxide induces cell death in cancerous cells. This approach is different from traditional treatments that typically use Tretinoin with chemotherapy and reserve Arsenic Trioxide for relapsed cases.126910
Research Team
Matthew A Kutny
Principal Investigator
Children's Oncology Group
Eligibility Criteria
This trial is for patients newly diagnosed with acute promyelocytic leukemia (APL), confirmed by bone marrow or blood tests, and who have the PML-RARalpha transcript. They can't have had previous APL treatments except certain steroids, hydroxyurea, or up to 5 days of ATRA. Pregnant women, breastfeeding mothers, those with heart issues like prolonged QT syndrome or significant arrhythmias are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Therapy
Patients receive tretinoin and arsenic trioxide, with additional treatments for high-risk patients, to achieve hematologic complete remission
Consolidation Therapy
Patients receive tretinoin and arsenic trioxide in cycles to consolidate remission
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Arsenic Trioxide
- Tretinoin
Arsenic Trioxide is already approved in United States, European Union for the following indications:
- Acute promyelocytic leukemia (APL)
- Acute promyelocytic leukemia (APL)
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Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator