Arsenic Trioxide for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I trial tests the safety, side effects, best dose and how well arsenic trioxide works to prevent relapse in patients undergoing allogenic stem cell transplantation for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Chemotherapy drugs, such as arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving arsenic trioxide may be safe, tolerable and/or effective in preventing relapse in patients undergoing allogenic stem cell transplant for AML or MDS.
Who Is on the Research Team?
John M Magenau
Principal Investigator
University of Michigan Rogel Cancer Center
Are You a Good Fit for This Trial?
This trial is for people with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who are scheduled to have an allogeneic stem cell transplant. Participants must meet specific health requirements and not have conditions that would make the treatment unsafe.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Arsenic Trioxide
- Busulfan
- Fludarabine
Trial Overview
The study is testing if adding arsenic trioxide after a stem cell transplant can safely help prevent cancer from coming back in AML or MDS patients. All participants receive standard chemotherapy and a transplant, plus arsenic trioxide at different doses.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive arsenic trioxide IV on days -6 to -2 and days +1 to +5 in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care fludarabine and busulfan on days -5 to -2 and allogenic hematopoietic stem cells IV on day 0. Patients undergo bone marrow biopsy, and blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
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