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Clofarabine followed by Fludarabine, Busulfan, Total-Body Irradiation and Hematopoietic Stem Cell Transplant with Post-Transplant Cyclophosphamide for Non-remission Acute Myeloid Leukemia (PSCI-18-011)

This research study is for patients with acute myeloid leukemia (AML) that do not see improvement in their condition with the usual chemotherapy, and who have decided with their doctor to continue treatment with a stem cell transplant. Normal preparation for a stem cell transplant includes pre-treatments that help the body accept donor cells. This is a process called conditioning. The purpose of this study is to understand how both AML and the body respond when a chemotherapy medication called clofarabine is given in the days before the transplanted donor stem cells are received. The researchers will study whether this experimental treatment improves how well the stem cell transplant works when it is used in combination with the usual pre-transplant conditioning.
Rachael Griffith at rgriffith2@pennstatehealth.psu.edu or 717-531-7128
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04002115
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Inclusion Criteria:
Acute myeloid leukemia (AML) that did not get better, or got worse, after two rounds of the usual treatment
18 to 75 years of age
Planned or scheduled to receive a blood stem cell transplant (the donor may be related or unrelated)
Organ function testing within 28 days of study registration
Use of an approved method of birth control and/or abstinence (men and women)
Exclusion Criteria:
Acute promyelocytic leukemia (APL), or central nervous system (CNS) leukemia
Previous transplant from a donor within the past 6 months, or if the planned transplant uses umbilical cord blood
Known history of non-compliance with medication regimens, scheduled clinic visits, or self-care
HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive
Active Hepatitis B and Hepatitis C
Cancer
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Location
Hershey, PA