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Clinical Trial Detail

Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies

Complete title: Phase I/IIA Study of the Oral 5-Azacitidine in Combination with the Histone Deacetylase Inhibitor Romidepsin for the Treatment of Patients with T-Cell Lymphoma

Research Study Number 9871
Principal Investigator Andrei Shustov, MD
Phase I/II

Research Study Description

This is an open label, phase I/IIa, 3 x 3 dose escalation study with an initial phase I followed by a disease focused phase II. The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. The safety and toxicity of this combination will be evaluated throughout the entire study. If the combination of oral 5-azacitidine and romidepsin is found to be feasible and an MTD is established, the phase II part of the study will be initiated. Phase II will consist of a 2 stage design of the combination of oral 5-azacitidine and romidepsin for patients with relapsed or refractory T-cell lymphomas

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "LOOK UP TRIAL AT NIH" link above. **

Other eligibility criteria may apply.

Research Study Number 9871
Contact Seattle Cancer Care Alliance Intake Office
Telephone 800-804-8824 / 206-606-1024

Keywords: Lymphoma, Burkitt; Hematologic Malignancies; Lymphoma, Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphoma, Non-Hodgkin (NHL); Immunoproliferative Disorders; Waldenstrom Macroglobulinemia; Lymphoma, Mantle-Cell; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Follicular; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, T-Cell, Cutaneous; Lymphoma, Large B-Cell, Diffuse; Immune System Diseases; Lymphoma, Marginal Zone

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