Pembrolizumab + Pralatrexate for Peripheral T-Cell Lymphoma

Recruiting at 2 trial locations

Overseen by Alex F Herrera

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial studies the combination of pralatrexate and pembrolizumab in patients with peripheral T-cell lymphomas that have returned or not responded to treatment. Pralatrexate blocks cancer cell growth, while pembrolizumab boosts the immune system to attack cancer cells. The goal is to find the best dose and see how well this combination works.

Research Team

Alex F Herrera

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for patients with peripheral T-cell lymphomas that have relapsed or are treatment-resistant. Participants must be in good physical condition (ECOG 0-1), not pregnant, willing to use contraception, and have measurable disease. They should have adequate organ function and blood counts, no severe infections or heart failure, and cannot have had certain other treatments recently.

Inclusion Criteria

Your kidneys can clean at least 60 milliliters of blood per minute based on a specific formula.

My lymphoma diagnosis is confirmed and matches WHO's classification.

I have received a vitamin B12 shot and started folic acid before starting pralatrexate.

Exclusion Criteria

I have adult T-cell leukemia/lymphoma.

I was treated with specific immune therapies but did not respond.

I have active hepatitis B or C.

Treatment Details

Interventions

• Pembrolizumab (PD-1 Inhibitor)
• Pralatrexate (Anti-metabolites)

Trial Overview The trial is testing the combination of Pembrolizumab (an immunotherapy drug) with Pralatrexate (a chemotherapy agent) to see if they're more effective together against T-cell lymphoma. It's a phase I/II study which means it's looking at the right dose as well as how well the drugs work.

Participant Groups

Group I: Treatment (pralatrexate and pembrolizumab) Experimental Treatment 2 Interventions

Patients receive pralatrexate IV over 3-5 minutes on days 1 and 8 and pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+