Romidepsin + Parsaclisib for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose of parsaclisib when combined with romidepsin (Istodax) for treating T-cell lymphomas that have recurred or resisted standard treatments. It also evaluates the effectiveness of these drugs in achieving cancer remission and improving survival. Romidepsin stops cancer cells from dividing, while parsaclisib blocks a pathway that promotes cancer cell growth. Individuals with T-cell lymphomas who have not responded to at least one systemic therapy may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires that all cancer therapy, including radiation, topical steroids, and chemotherapy, must be stopped at least 1 week or 3 half-lives before starting the study treatment. However, if you have been on corticosteroids for a long time without changes, you may continue using them if the dose hasn't changed for 14 days before the study.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that romidepsin, a drug for certain types of T-cell lymphoma, has been tested in several studies. In these studies, some patients experienced side effects like blood issues and general discomfort. However, the FDA has approved romidepsin for treating cutaneous T-cell lymphoma, indicating its safety for that condition.
Parsaclisib is a newer drug that inhibits enzymes aiding cancer cell growth. As a new drug, less information is available, but ongoing tests aim to determine its safety and effectiveness.
Researchers are investigating the combined use of romidepsin and parsaclisib, as they might work better together than separately. While this combination is still in early testing, the established safety of romidepsin offers some reassurance. However, the full safety of using both drugs together remains under study, and this trial is a crucial step in gaining more insight.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of romidepsin and parsaclisib for lymphoma because it targets the cancer in a novel way. Unlike traditional treatments that focus primarily on chemotherapy, this combo includes parsaclisib, a PI3K inhibitor, which interferes with pathways crucial for cancer cell survival and proliferation. In addition, romidepsin, a histone deacetylase inhibitor, can help make the cancer cells more sensitive to treatment. By using this unique dual approach, there's potential to improve outcomes and offer hope to patients who may not respond well to existing therapies.
What evidence suggests that romidepsin and parsaclisib might be effective for T-cell lymphomas?
Research has shown that romidepsin, when used alone, has been somewhat successful in treating cutaneous T-cell lymphoma. In one study, about 34% of patients experienced a reduction or disappearance of their cancer. Parsaclisib works differently by blocking a pathway called PI3K, which cancer cells need to grow and survive. By blocking this pathway, parsaclisib may help stop cancer cells from multiplying. In this trial, participants will receive a combination of romidepsin and parsaclisib. The goal of combining these two drugs is to enhance their effectiveness. Although solid data on the combination's efficacy is not yet available, the expectation is that they might work better together than each drug alone.678910
Who Is on the Research Team?
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
Exclusion Criteria
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.
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.
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.
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.
What Are the Treatments Tested in This Trial?
Interventions
- Parsaclisib
- Romidepsin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
Walter Hanel
Lead Sponsor