A Phase I Non-Randomized Study of TP53 Reactivation With Arsenic Trioxide in Allogeneic Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndrome
University of Michigan Rogel Cancer Center
Summary
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.
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * AML or MDS patients eligible to receive first allogeneic HCT. Eligibility inclusion for HCT is defined as per University of Michigan bone marrow transplant (BMT) standard of care criteria * Presence of high-risk AML/MDS with probable biallelic TP53 deletion or mutation status, defined by one of the following in prior blood or bone marrow assessments: * TP53 loss by karyotype (chromosome 17 or 17p deletion) or single nucleotide polymorphism (SNP) (Cancer Microarray) AND ≥ one clonal TP53 mutation by next generation sequencing (NGS) (VAF \> 10%). * ≥ one TP53 mutation…
Interventions
- ProcedureAllogeneic Hematopoietic Stem Cell Transplantation
Given IV
- DrugArsenic Trioxide
Given IV
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy
- DrugBusulfan
Given IV
- DrugFludarabine
Given fludarabine
Location
- University of Michigan Rogel Cancer CenterAnn Arbor, Michigan