Clinical Trial TitleAn open label, phase I/II study to evaluate the safety and efficacy of tenalisib (RP6530), a novel PI3K δ/γ dual inhibitor, given in combination with a histone deacetylase inhibitor, romidepsin, in adult patients with relapsed/refractory T-cell lymphoma.
Clinical Trial Protocol Description:
The purpose of this study is to evaluate safety and to find the highest tolerable dose of tenalisib in combination with romidepsin in patients with T-cell lymphoma (TCL). The study is also looking to see how the body processes both tenalisib and romidepsin when given together. Another goal of this study is to learn if tenalisib in combination with romidepsin can help to control TCL better.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have pathologically confirmed T-cell lymphoma at the enrolling institution.
- Have disease status as defined as relapsed after or refractory to at least one systemic therapy.
- Have received NOT more than three prior systemic combination chemotherapies.
- Have ECOG performance status ≤ 2.
You will be excluded from the study if any of the following criteria apply to you:
- Are receiving anticancer therapy including any investigational therapy (e.g. chemotherapy, biologic therapy, hormonal therapy, radiotherapy [except limited field palliative radiation], surgery and/or tumor embolization) ≤3 weeks or 5 half-lives (whichever is shorter) prior to C1D1.
- Have discontinued prior therapy with PI3K inhibitors or HDAC inhibitors due to drug toxicity.
- Have medical conditions requiring the use of systemic immunosuppressive medications (> 20 mg/day of prednisone or equivalent).
- Have a history of chronic liver disease, hepatic veno-occlusive disease, or current alcohol abuse.
This is a partial list of inclusion and exclusion criteria.