Clinical Trial TitleJSP191 Antibody Targeting Conditioning in MDS/AML Patients Undergoing Hematopoietic Cell Transplantation
National Clinical Trial Number:NCT04429191
Clinical Trial Protocol Description:
The study is looking at an investigational conditioning drug, JSP191, which may be less toxic than other bone marrow transplant preparative therapy (called conditioning) of low dose radiation and fludarabine in adults with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) who will be having allogeneic hematopoietic cell transplantation (HCT). “Investigational” means that the drug has not been approved by the U.S. Food and Drug Administration (FDA) and it must be tested to see if it is a safe and effective treatment for the disease or condition being studied.
Participants in the study will receive JSP191 intravenously on study Day 0. Blood levels of JSP191 will be measured at regular intervals following infusion of JSP191 to determine when the level of JSP191 is at the appropriate level to begin the standard conditioning regimen. The standard conditioning therapy will begin on transplant Day 4 (4 days before donor cell infusion). The standard conditioning regimen is three doses of a chemotherapy drug called fludarabine and then a single dose of total body irradiation to treat cancer cells and to weaken the immune system sufficiently so that the donor cells will grow and function.
After completing conditioning therapy, participants will receive an infusion of the donor hematopoietic cells, which will occur on transplant Day 0. The participant’s blood and immune system will be replaced by the donor’s blood and immune cells. The drugs sirolimus, tacrolimus, and mycofenolate mofetil (immune suppressing medicines) will also be infused to prevent graft versus host disease. Graft versus host disease is an immune reaction of the donor’s hematopoietic cells against your body tissues. In some cases, other medications may be used. Supportive medications and blood transfusions may also be administered.
Participation in the study may last up to 2 years post-transplant. The participant’s health status will be followed life-long after transplantation.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are a candidate for allogeneic HCT for MDS or AML.
- Have a diagnosis of MDS or AML and are 60 years of age or older OR are 18 years of age or older but younger than 60 years of age, and deemed not a candidate for HCT using myeloablative conditioning.
- Have highest MDS IPSS-R since diagnosis, of less than 3.5 (includes Low and Very Low Subgroups) with poor risk features, less than 5% BM blasts at diagnosis; poor risk features defined as: poor-risk cytogenetic characteristics; or life-threatening cytopenias.
You will be excluded from the study if any of the following criteria apply to you:
- Have any acute or uncontrolled infections.
- Have had another malignancy diagnosed within 2 years prior, with the exception of localized skin cancers, carcinoma in situ of the uterine cervix, or localized prostate cancer.
- Have had a prior allogeneic HCT.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.