Myelodysplastic Syndrome Clinical Trial
FLT-PET Imaging for MDS
Summary
The main purpose of this study is to see if this tracer can be used to determine how well chemotherapy is working in patients with certain types of leukemia.
Full Description
Primary objectives
To evaluate if FLT-PET uptake shows variation during the treatment course in subjects with MDS being treated with 5-azacitidine therapy
Secondary objectives
To assess FLT-PET uptake heterogeneity within given subjects being treated with 5-azacitidine therapy
To generate preliminary data regarding correlation between FLT-PET imaging parameters and clinical responses based on bone marrow aspirate/biopsy
Eligibility Criteria
Inclusion Criteria:
All subjects with previously untreated, Intermediate-2 or High risk myelodysplastic syndrome are eligible. These patients have an international prognostic scoring system (IPSS) score of 1.5 to 3.5 based on bone marrow blast percentage, karyotype, and the number of cytopenias 26.
Subjects will receive the standard FDA-approved dose and schedule of 5-azacitidine. This dose is 75mg/m2 SQ or IV daily for seven days with cycles repeated every 28 days
The subject's treating physician must have an initial intent of treating with at least four cycles of therapy
Subjects must have an ECOG performance status of 0, 1, or 2
Subjects must not have been treated with chemotherapy or radiation for another malignancy within the preceding 6 months
Subjects must be > 18 years of age
Subjects must have a serum creatinine < 2.0 mg/dL and/or calculated GHF 50 ml/min/1.73m (MRDR formula) or greater
Subjects must have a serum direct bilirubin < 2.0 mg/dL unless related to Gilbert's syndrome of hemolysis. Alkaline phosphatase, SGOT (AST), and SGPT (ALT) must be less than 4 x upper limit of normal
Women must not be pregnant nor breastfeeding
Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
Exclusion Criteria:
Subjects who are pregnant or breast feeding
Subjects for whom a therapy other than 5-azacitidine is recommended as first line treatment.
Allogeneic stem cell transplantation in patients with a suitable donor, lack of comorbidities, and good performance status
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There is 1 Location for this study
Madison Wisconsin, 53792, United States
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