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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02846935
Study type Interventional
Source Case Comprehensive Cancer Center
Contact
Status Completed
Phase Early Phase 1
Start date April 25, 2017
Completion date January 22, 2018

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