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An Open label, Phase I/II study to evaluate the safety and efficacy of Tenalisib (RP6530), a novel PI3K dual inhibitor given in combination with a histone deacetylase (HDAC) inhibitor, Romidepsin in adult patients with relapsed/refractory T-cell Lymphoma

Study category: Cancer

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Details
Age

Adult

Phase

I/II - A combination of phases: (1) Research Studies that focus on the safety of a drug. The goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These studies usually involve a small number of participants; and (2) Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Locations

Lone Tree Medical Center
University of Colorado Hospital

Principal Investigator
Brad Haverkos,  MD

Brad Haverkos, MD

Study ID

Protocol Number: 19-1431

ClinicalTrials.gov: NCT03770000

Categories

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