Tretinoin + Arsenic Trioxide (+/- Gemtuzumab) for Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This study is evaluating whether a combination of drugs may help treat acute promyelocytic leukemia.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the combination of Tretinoin and Arsenic Trioxide safe for treating leukemia?
The combination of Tretinoin (all-trans retinoic acid) and Arsenic Trioxide has been used to treat acute promyelocytic leukemia and is generally well tolerated. Common side effects include fatigue, rash, fluid retention, and changes in heart rhythm, but serious side effects are rare. Studies have shown that this treatment can be safe when used at recommended doses.12345
What makes the drug combination of Tretinoin and Arsenic Trioxide unique for treating leukemia?
This drug combination is unique because Arsenic Trioxide is highly effective in treating acute promyelocytic leukemia (APL), especially in relapsed cases, and when combined with Tretinoin, it can improve event-free and overall survival rates. Additionally, this combination can achieve complete molecular remission even in patients with resistant forms of the disease, offering a novel approach compared to traditional chemotherapy.26789
What data supports the effectiveness of the drug arsenic trioxide in treating leukemia?
Arsenic trioxide has shown to be highly effective in treating acute promyelocytic leukemia (APL), achieving complete remission in over 80% of patients with relapsed disease and improving event-free survival when used as part of consolidation therapy. It has also been studied in other types of leukemia, showing some effectiveness when combined with other drugs.278910
Who Is on the Research Team?
Farhad Ravandi-Kashani
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with a new diagnosis of acute promyelocytic leukemia (APL) confirmed by specific genetic tests. Participants must understand the study and agree to sign consent forms. Those who have started emergency APL treatment can join, and women of childbearing age need negative pregnancy tests before and during the study. Contraception use is required for all sexually active participants.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Patients receive tretinoin orally twice daily, arsenic trioxide intravenously over 1-2 hours daily, and gemtuzumab ozogamicin intravenously over 2 hours once at weeks 1-4
Consolidation
Patients achieving complete response receive arsenic trioxide IV 5 days per week during weeks 1-4, 9-12, 17-20, and 25-28 and tretinoin PO BID for 2 weeks on and 2 weeks off. Treatment repeats every 8 weeks for up to 4 courses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Arsenic Trioxide
- Gemtuzumab Ozogamicin
- Tretinoin
Arsenic Trioxide is already approved in United States, European Union for the following indications:
- Acute promyelocytic leukemia (APL)
- Acute promyelocytic leukemia (APL)
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator