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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Given IV
Given IV
Undergo blood sample collection
Undergo bone marrow biopsy
Given IV
Given fludarabine
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Incidence of dose limiting toxicities
Assessed via the incidence and severity of adverse events as graded by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
Time frame: From baseline to day 35 post hematopoietic stem cell transplant (HCT)
Progression free survival (PFS)
Malignancy relapse is defined as: evidence of persistent morphological or cytogenetic findings of acute leukemia or myelodysplastic syndrome consistent with pretransplant features occurring after primary neutrophil engraftment or day 35, whichever occurs sooner. Progression-free survival (PFS) is defined as the duration of time from HCT (Day 0) to time of death or progression of primary malignancy detected by bone marrow assessment or other clinical monitoring. Will be estimated using Kaplan-Meier methods, with specific focus on estimates and 95% confidence intervals for PFS at 6- and 12-months. If no loss to follow-up is observed, then PFS will be estimated using observed proportions.
Time frame: At 6 and 12 months post HCT
Absolute neutrophil recovery
Engraftment for neutrophils is defined as the first of three consecutive days in which the absolute neutrophil count is \> 500/uL.
Time frame: From day 0 to day 35 post HCT
Incidence of severe cardiac arrythmia
Defined as grade 3 or greater cardiac arrythmia by CTCAE v 5.0.
Time frame: From baseline to day 35 post HCT
Incidence of hepatic sinusoidal obstruction syndrome/veno-occlusive disease
Any Grade 3 or greater SOS/VOD by CTCAE v5.0 by day 35 post HCT will be considered for meeting this endpoint.
Time frame: From baseline to day 35 post HCT
PFS
Defined as whether a subject is alive and free of relapse. Will be estimated using Kaplan-Meier methods, with specific focus on estimates and 95% confidence intervals for PFS at 6- and 12-months. If no loss to follow-up is observed, then PFS will be estimated using observed proportions.
Time frame: At 12 months post HCT
Incidence of non-relapse mortality (NRM)
An event for NRM is death without prior evidence of relapse/progression of the primary disease, where relapse/progression is treated as a competing risk. Will be estimated using the methods of Fine and Gray in order to treat death as a competing event, rather than a censoring event.
Time frame: At 6 and 12 months post HCT
Incidence of acute graft versus host disease
Will be estimated using the methods of Fine and Gray in order to treat death as a competing event, rather than a censoring event.
Time frame: At 6 months post HCT
Incidence and severity of chronic graft versus host disease
Will be estimated using the methods of Fine and Gray in order to treat death as a competing event, rather than a censoring event.
Time frame: At 6 and 12 months post HCT
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