Cancer

Title
Maintenance Therapy with Azacitadine and Valproic Acid after Allogeneic Stem Cell Transplant in Participants with High-Risk Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Trial Number
203835
Number of Participants
39
Principal Investigator

Patrick Stiff

M.D.
Hematology/Oncology
Coleman Professor of Oncology
Eligibility

Inclusion Criteria:

1) Age greater than 18 years.

2) Participants must be younger than 55 with refractory or relapsed: acute myelogenous leukemia (AML) (including inv16, t(8;21) or t(15;17)) or high-risk myelodysplastic syndrome (MDS) (defined as bone marrow blasts greater than or equal to 5 percent) to be eligible. Individuals may be in remission at the time of entry.
3) Participants must exhibit adequate organ function and performance status criteria as measured by:
a)A Karnofsky score greater than or equal to 70 percent or performance status of less than or equal to two by the Eastern Cooperative Oncology Group (ECOG) scale.
b) Adequate liver function (bilirubin of less than 2 mg/dL, SGPT greater than 3 ULN) and renal function (creatinine less than 2 mg/dL).
4) Signed, informed consent indicating that individuals are aware of the investigational nature of this study in accordance with the regulations of Loyola University Medical Center.
5) Participants must have undergone allogeneic stem cell transplant within 40-60 days before starting treatment and be self-sufficient in caloric intake along with no active graft vs. host disease.

Purpose

The purpose of this research is to find out the good and bad effects of the combination of valproic acid and azacitadine in participants with with high-risk acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) after allogeneic stem cell transplant.

Enrollment

(708) 327-2241

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