This pilot early phase I trial studies how well decitabine and tetrahydrouridine work in treating patients with T- or B-cell lymphoma that are not responding to treatment and have come back. Decitabine and tetrahydrouridine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02846935.
PRIMARY OBJECTIVES:
I. To determine the objective response rate to oral tetrahydrouridine (THU)-decitabine (Dec) in patients with 3 separate biologic subsets of refractory/relapsed lymphoid malignancies T-cell lymphoma, aggressive B cell lymphoma, and indolent B-cell lymphoma.
SECONDARY OBJECTIVES:
I. To evaluate the toxicity of oral THU-Dec in these patients.
TERTIARY OBJECTIVES:
I. To evaluate hypotheses regarding mechanisms of resistance and predictive biomarkers.
OUTLINE:
INDUCTION: Patients receive tetrahydrouridine orally (PO) and decitabine PO for 5 consecutive days in weeks 1 and for 2 consecutive days in weeks 2-4 in the absence of disease progression or unacceptable toxicity. Patients may receive another course of Induction if clinically indicated.
MAINTENANCE: Patients receive tetrahydrouridine PO and decitabine PO twice per week on consecutive days. Treatment repeats every 4 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorBrian Thomas Hill
