A Phase 1/2 Study to Evaluate the Safety and Efficacy of JSP191 in Combination with a Reduced Intensity Conditioning Regimen of Low Dose Radiation and Fludarabine in Patients with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) Undergoing Allogeneic Hematopoietic Cell Transplantation (HCT)
The purpose of the study is to learn more about an investigational drug, called JSP191, which may be helpful in treating Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia when given before a stem cell transplant.
We are hoping to find out if the study drug along with chemotherapy and radiation can be given safely to participants before a stem cell transplant and to find the best dose for further research. Another goal is to find out if stem cell transplants may be as effective when a ‘reduced intensity’ preparation regimen of chemotherapy and radiation with the investigational drug is given compared to a standard preparation regimen (also called a ‘conditioning regimen’).
Acute Myelogenous Leukemia (AML)
Myelodysplastic Syndrome (MDS)
Participants must be 60 years of age or older or between 18 and 60 years of age and either documented to be ineligible for standard conditioning therapy OR with other conditions (such as heart problems, diabetes, or problems with other organs such as liver, kidneys, or lungs).
Participants must have a suitable stem cell donor for a stem cell transplant.
Participants cannot have an active infection, a different form of cancer within the past two years (with some exceptions), or had a previous stem cell transplant.
18 - 120
Healthy Volunteers Needed
Duration of Participation
Participation in the study will consist of about 35 visits over 1 year. We will ask to follow your health through the use of medical record review or follow-up phone calls for up to 1 year. Anyone who receives a stem cell transplant with cells from a donor are followed for the rest of their life, and data about the diagnosis, treatment, recovery, and health status is collected.
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