5 Participants Needed

Romidepsin + Parsaclisib for Lymphoma

TO
Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

WH

Walter Hanel, MD, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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
See 13 more

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
See 12 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (romidepsin, parsaclisib)Experimental Treatment2 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.

Find a Clinic Near You

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+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security