← Back to Search

PD-1 Inhibitor

Pembrolizumab + Pralatrexate for Peripheral T-Cell Lymphoma

Phase 1 & 2
Waitlist Available
Led By Alex F Herrera
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a histologically confirmed diagnosis of mature peripheral T-cell or natural killer (NK)-cell lymphoma according to the World Health Organization (WHO) classification, with hematopathology review at the participating institution
Patients must have received one dose of vitamin B12 (1 mg intramuscularly [IM]) within 10 weeks prior to first dose of pralatrexate, and must have begun folic acid supplementation (1 mg orally, once daily) within 10 days of first dose of pralatrexate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights

Study Summary

This trial is studying pralatrexate and pembrolizumab to see how well they work in treating patients with peripheral T-cell lymphomas.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the drug entering the body, fatigue, liver enzyme changes, digestive issues like nausea or mouth sores from chemotherapy, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lymphoma diagnosis is confirmed and matches WHO's classification.
Select...
I have received a vitamin B12 shot and started folic acid before starting pralatrexate.
Select...
My blood clotting time is within the target range for my blood thinner medication.
Select...
My blood clotting time is within the target range for my anticoagulant therapy.
Select...
I am a woman who can have children and have a negative pregnancy test.
Select...
I am using two birth control methods or am not having sex to join this study.
Select...
My platelet count is at least 75,000/mm^3, or between 25,000 and 75,000/mm^3 if my lymphoma affects my bone marrow.
Select...
My cancer returned or worsened after at least one treatment.
Select...
My blood clotting time is near normal and I'm not on blood thinners.
Select...
I will use two forms of birth control or abstain from sex during and for 120 days after my treatment.
Select...
My white blood cell count is within the required range for the study.
Select...
I am willing and able to sign the consent form myself or have someone legally authorized to do so on my behalf.
Select...
I agree to provide a new or previous biopsy sample for the study.
Select...
I have a tumor that is larger than 1.5cm, confirmed by CT or PET scan.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My blood clotting time is within normal limits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose defined as the highest doe level at which < 2 out of 6 evaluable subjects experienced dose limiting toxicities (Phase I)
Overall response rate (ORR) according to Lugano classification (Phase II)
Secondary outcome measures
CR rate according to the International Harmonization Project response criteria
Complete response (CR) rate according to Lugano classification
Duration of response (DOR) based on Lymphoma Response to Immunomodulatory therapy Criteria (LYRIC) criteria
+5 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pralatrexate and pembrolizumab)Experimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Pralatrexate
FDA approved

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,439 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,633 Total Patients Enrolled
Alex F HerreraPrincipal InvestigatorCity of Hope Medical Center
11 Previous Clinical Trials
1,548 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03598998 — Phase 1 & 2
Peripheral T-Cell Lymphoma Research Study Groups: Treatment (pralatrexate and pembrolizumab)
Peripheral T-Cell Lymphoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03598998 — Phase 1 & 2
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03598998 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are currently participating in this research?

"To carry out this research, we need 40 individuals that fit the pre-determined inclusion criteria. Those who take part in this experiment can do so from various hospitals, like Emory University Hospital/Winship Cancer Institute in Atlanta or University of Nebraska Medical Center located in Omaha."

Answered by AI

Can patients still sign up for this research study?

"Correct, the clinicaltrial.gov website has information stating that this trial is looking for patients right now. The original posting date was February 4th, 2019 and the most recent update was on August 15th, 2022. They are recruiting 40 people to participate at 3 different locations."

Answered by AI

For what purpose is Pembrolizumab most often prescribed?

"Pembrolizumab is a medication that can be used to treat various conditions, such as unresectable melanoma or microsatellite instability high. It is most commonly taken to fight malignant neoplasms though."

Answered by AI

What are some other experimental treatments that have used Pembrolizumab?

"Pembrolizumab was first studied a decade ago, in 2010, at City of Hope. 272 studies have reached completion and there are 1002 more underway; many of these are based in Atlanta, Georgia."

Answered by AI
~2 spots leftby Mar 2025