Arsenic Trioxide for Acute Myeloid Leukemia

TC
Overseen ByTracey Churay
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Michigan Rogel Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

JM

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

I have AML or MDS and am eligible for my first stem cell transplant.
Availability of a peripheral blood stem cell product
Transthoracic echocardiogram with ejection fraction ≥ 50% at enrollment
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Exclusion Criteria

I do not have any uncontrolled infections.
HIV or HTLV 1/2 seropositivity or PCR positivity
Any physical, psychological or psychosocial condition posing unacceptable risk per investigator
See 8 more

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

Group I: Treatment (arsenic trioxide)Experimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+