Romidepsin + Parsaclisib for Lymphoma

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ohio State University Comprehensive Cancer Center

Must not be taking: Immunosuppressants, Strong CYP3A4 inhibitors

Disqualifiers: Uncontrolled CNS disease, Active infection, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

5 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a combination of two drugs, parsaclisib and romidepsin, for patients with T-cell lymphomas that have returned or not responded to standard treatments. Romidepsin stops cancer cells from dividing, while parsaclisib blocks a pathway that helps cancer cells grow. The goal is to find the best dose and see how well this combination works in reducing cancer and improving patient survival.

Research Team

Walter Hanel, MD, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

Adults with relapsed or refractory T-cell lymphomas, including various subtypes like Anaplastic Large Cell and Cutaneous T-Cell Lymphoma. Participants must have a life expectancy of at least 90 days, adequate organ function, no recent cancer treatments (with some exceptions for steroids), and not be pregnant. They should agree to use effective contraception.

Inclusion Criteria

Bilirubin =< 2.0 x ULN (<= 4 x ULN allowed for specific conditions)

Negative serum pregnancy test at enrollment for females of childbearing potential

Life expectancy >= 90 days

Exclusion Criteria

I have been treated with a PI3K inhibitor before.

I have not had any other cancer in the last 2 years, with some exceptions.

Unwillingness to comply with study procedures

Timeline

Pre-Phase

Patients receive romidepsin intravenously over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.

8 weeks

3 visits per cycle (in-person)

Induction Phase

Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and parsaclisib orally once daily on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.

8 weeks

3 visits per cycle (in-person)

Maintenance Phase

Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and parsaclisib orally once daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Ongoing

3 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs at 30 days post-treatment and then every 3 months for up to 2 years.

Up to 2 years

1 visit at 30 days, then every 3 months

Treatment Details

Interventions

• Parsaclisib
• Romidepsin

Trial Overview The trial is testing the combination of Romidepsin and Parsaclisib to find the best dose for treating T-cell lymphomas that haven't responded well to other treatments. It aims to see if this combo can achieve complete remission or significant reduction in cancer size and improve patient survival.

Participant Groups

Group I: Treatment (romidepsin, parsaclisib) Experimental Treatment 2 Interventions

PRE-PHASE: Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. INDUCTION PHASE: Patients receive romidepsin IV over 4 hours on days 1,8, and 15 and parsaclisib PO QD on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and parsaclisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Walter Hanel

Lead Sponsor

Trials

1

Recruited

5+