Ziftomenib Maintenance After Transplant

This is a prospective, multi-center, open-label, phase I study of ziftomenib as maintenance therapy following allogeneic hematopoietic cell transplantation (HCT). This study is testing whether ziftomenib, combined with the standard allo-HCT treatment, is safe and effective in treating blood cancer. This study will test if ziftomenib improves outcomes after allo-HCT. The study drug is given after the allo-HCT, in combination with standard treatment and aftercare.

This study consists of 2 parts: Part A (Dose Escalation): The investigators are looking to find the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the study intervention. The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tolerated.

The purpose of this study is to test the safety, effects, and recommended dose of an investigational drug, ziftomenib, in addition to the standard treatment on blood cancer with Allogeneic Hematopoietic Cell Transplantation (allo-HCT). This study plans to learn more about ziftomenib, which targets and inhibits negative interactions within cancer cells related to AML, when given after allo-HCT, to determine if it improves outcomes following allo-HCT.

The name of the study drug involved in this study is: • Ziftomenib

Live record on ClinicalTrials.gov →

• Pathologically confirmed diagnosis of acute myeloid leukemia (AML).
• Complete remission (CR) or complete remission with incomplete count recovery (CRi) at screening.
• no circulating blasts in peripheral blood and <5% blasts in bone marrow
• no extramedullary disease
• platelet count ≥100 x 10(9)/L and/or absolute neutrophil count ≥1000/µL

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.