IRB #

STUDY00019561

Title

An 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 (HDAC) inhibitor, Romidepsin in adult patients with relapsed/refractory T-cell Lymphoma

Principal Investigator

Craig Okada

Study Purpose

The purpose of this study is to find out the effects, good or bad, when study drug tenalisib is given in combination with approved drug romidepsin in participants with relapsed and/or refractory T-cell lymphoma. Other primary objectives of this study are to find out the highest tolerable dose of tenalisib in combination with romidepsin, and learn how the body handles absorption, distribution and excretion of the study drug and romidepsin. This is an investigational combination and is not approved anywhere in the world.

Medical Condition(s)

- T-cell lymphoma (TCL)
- Cutaneous T-cell lymphoma (CTCL)
- Peripheral T-cell lymphoma (PTCL)

Eligibility Criteria

- Men and women at least 18 years of age with confirmed diagnosis of T-cell lymphoma
- Participants must be relapsed after or refractory to at least one systemic therapy
- Participants must not have received more than three prior systemic combination chemotherapies

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Participants may receive study drug therapy for up to 7 cycles (7 months). After 7 cycles, if participants are benefiting from treatment, they will be given an opportunity to participate in a compassionate use study based on the investigator’s decision. If the investigator thinks that they are benefiting, then they may be able to take the study drug up to 2 years (26 cycles). After participants have completed their last dose of study drug, the investigator will watch them for side effects for 30 days.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Rhizen Pharmaceuticals SA

Recruitment End

01/01/2022

Compensation Provided

No


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