Can a poison become a cure? arsenic trioxide put to the test in blood cancer transplant
NCT ID NCT07737769
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This early-phase trial tests whether adding arsenic trioxide to a standard stem cell transplant can prevent the cancer from coming back in people with high-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The study enrolls about 20 patients whose cancers have a specific genetic flaw (TP53 mutation). The main goal is to check the safety and best dose of arsenic trioxide in this setting, while also watching for signs that it might keep the cancer in remission.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- arsenic trioxide given alongside an allogeneic stem cell transplant
- What this could lead to
- If it works, this could point toward a way to prevent relapse and improve long-term survival for people with high-risk blood cancers.
- What could go wrong
- This is a very early, small phase I trial focused on safety and dosing, so it is unknown whether arsenic trioxide will actually prevent relapse. Arsenic trioxide can cause serious side effects, including heart rhythm problems and liver damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Nov 2026
An estimate. Start dates often move.
- Expected to finish
-
Nov 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 by NGS testing (with VAF \> 40%) * ≥ two distinct TP53 mutation(s) by NGS (VAF \>10%) * Evidence that at least one TP53 allele harbors a structural TP53 missense mutation. In cases where the mutation type is unclassified, molecular pathology assessment is required to determine if one of the lesions is a missense mutation (as described in NGS report) * Patients may be enrolled with either active disease or in morphological remission, provided the bone marrow blast count on the pre-HCT assessment does not exceed 30% * Age \> 21 years at enrollment and receiving allogeneic HCT in the adult transplant program * Karnofsky performance score (KPS) ≥ 70% * Documentation of adequate pulmonary function by forced expiratory volume and 1 second (FEV1) ≥ 50% of predicted, forced vital capacity (FVC) ≥ 50% of predicted and DLCO (corrected for hemoglobin) ≥ 50% of predicted (must meet all criteria at time of enrollment based on standard of care pre HCT testing) * Transthoracic echocardiogram with ejection fraction ≥ 50% (must meet all criteria at time of enrollment based on standard of care pre HCT testing) * Estimated glomerular filtration rate ≥ 50% ml/min/1.73m\^2 by the Cockcroft-Gault equation. Glomerular filtration rate (GFR) should be corrected for body surface area (BSA) (must meet all criteria at time of enrollment based on standard of care pre HCT testing) * Total bilirubin ≤ 2 x upper limit of normal (unless directly attributed to Gilbert's Syndrome) (must meet all criteria at time of enrollment based on standard of care pre HCT testing) * Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 5 x upper limit of normal (must meet all criteria at time of enrollment based on standard of care pre HCT testing) * Electrocardiogram (ECG) with corrected QT (QTc) ≤ 450 msec (using the Framingham correction) (must meet all criteria at time of enrollment based on standard of care pre HCT testing) * Availability of an 8 of 8 HLA matched unrelated donor with matching at HLA A, B, C and DRB1 * Availability of a peripheral blood stem cell (PBSC) product * Ability to understand and the willingness to sign a written informed consent * Willingness to agree to use adequate contraception methods (subjects of reproductive potential only): * Females of reproductive potential must agree to use effective contraception (e.g., hormonal contraception, intrauterine device, tubal occlusion, vasectomized partner, abstinence) during treatment with ATO and for 6 months after the final dose. * Males with female partners of reproductive potential must agree to use effective contraception during treatment with ATO and for 3 months after the final dose Exclusion Criteria: * Uncontrolled infections. Patients still under therapy for presumed or proven infection are eligible provided there is clear evidence (radiologic, clinical and/or culture) that the infection is well controlled * Patients may NOT have evidence or symptoms of central nervous system (CNS) disease at the time of enrollment * HIV or human t-lymphotropic virus (HTLV) 1 / HTLV 2 (seropositivity and/or polymerase chain reaction \[PCR\] positivity) * Pregnant and nursing mothers are excluded * Any physical, psychological or psychosocial condition that, in the opinion of the investigator, would pose unacceptable risk to the patient * Other malignancy requiring systemic therapy or with life expectancy of \< 1 year * Receipt of prior allogeneic HCT * History of severe cardiac conduction abnormalities (complete heart block, Left Bundle Branch Block, Torsades de Pointes, or other ventricular arrythmias). History of any cardiac arrhythmia (e.g. rate controlled atrial fibrillation) is not an exclusion * QTc \> 450 msec (using the Framingham correction) * Patients under 40 years of age at time of evaluation will be screened for Shwachman-Diamond syndrome (SDS), which is a rare, inherited disorder characterized primarily by exocrine pancreatic insufficiency, bone marrow failure, and skeletal abnormalities. These patients commonly progress to myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Given potential for increased liver toxicities in this population, these patients will be excluded from the study. All patients under 40 years old will be screened through the University of Michigan Prevention Genetics Clinic prior to enrollment * Patients with known hypersensitivity to arsenic
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute myeloid leukemia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Platelet-Boosting drug help control a rare bone marrow disorder?
- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?