T-cell Lymphoma Clinical Trial
Official title:
p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Refractory/Relapsed Lymphoid Malignancies
The purpose of this study is to evaluate how well the study drug works and safety of oral decitabine in patients with refractory or relapsed lymphoid malignancies. The decitabine is being given at a lower dose than used for its approved use. It is also being given with another drug, tetrahydrouridine (THU), to improve the exposure of lymphoma cells to decitabine.
Primary objective: To determine the objective response rate to oral THU-Dec in patients with
3 separate biologic subsets of refractory/relapsed lymphoid malignancies:
1. T-cell lymphoma,
2. Aggressive B cell lymphoma,
3. indolent B-cell lymphoma .
Secondary objectives:
(i) To evaluate the toxicity of oral THU-Dec in these patients; (ii) To evaluate hypotheses
regarding mechanisms of resistance and predictive biomarkers.
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