Arsenic Trioxide to Prevent Relapse in Patients Undergoing Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia or Myelodysplastic Syndrome

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor: University of Michigan Rogel Cancer Center
Study ID: NCT07737769
Phase: PHASE1
Status: Not Yet Recruiting

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Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndrome

Eligibility Criteria

Sex: ALL
Age: 21 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
Given IV
Arsenic Trioxide — DRUG
Given IV
Biospecimen Collection — PROCEDURE
Undergo blood sample collection
Bone Marrow Biopsy — PROCEDURE
Undergo bone marrow biopsy
Busulfan — DRUG
Given IV
Fludarabine — DRUG
Given fludarabine

Study Details

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.

Key Dates

First listed: Jul 30, 2026
Start date: Nov 30, 2026
Status verified: Jul 2026
Primary completion: Nov 30, 2028
Completion: Nov 30, 2029

Study Design

Enrollment: 20 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Treatment (arsenic trioxide)
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.