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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
If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants
Must not have
Patients with adult T-cell leukemia/lymphoma
Patients who received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent without having had evidence of objective response
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 43 months after the initial study treatment.
Awards & highlights

Summary

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.

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.
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.
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
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My lymphoma diagnosis is confirmed and matches WHO's classification.
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My blood clotting time is within the target range for my anticoagulant therapy.
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My blood clotting time is near normal and I'm not on blood thinners.
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I have a tumor that is larger than 1.5cm, confirmed by CT or PET scan.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My blood clotting time is within normal limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have adult T-cell leukemia/lymphoma.
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I was treated with specific immune therapies but did not respond.
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I have active hepatitis B or C.
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I have had tuberculosis in the past.
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I have an autoimmune disease treated with medication in the last 2 years.
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I have been diagnosed with HIV.
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I have an infection that needs treatment with medication.
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I haven't had cancer drug therapy or major surgery in the last 3 weeks.
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I had a stem cell transplant from a donor within the last 5 years.
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I had a stem cell transplant using my own cells within the last 2 months.
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I took pralatrexate before but it didn't shrink my cancer.
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I haven't taken any experimental cancer drugs or antibodies in the last 21 days.
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I haven't had cancer treatment or recovered from its side effects in the last 14 days.
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I have been diagnosed with an immune system disorder.
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I have severe limitations due to heart failure.
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My lymphoma has spread to my brain or spinal cord.
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I am not pregnant or breastfeeding.
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I have had pneumonitis treated with steroids or have it now.
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I have another cancer that is getting worse or needs treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 43 months after the initial study treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 43 months after the initial study treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Who Had Dose Limiting Toxicities
Number of Participants Who Had Overall Response
Secondary study objectives
Number of Participants Who Had Complete Response (CR)
Number of Participants With Grade 3 4 5 Adverse Events

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Pneumonia aspiration
3%
Sepsis
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Peripheral T-Cell Lymphoma (PTCL) include pralatrexate and pembrolizumab. Pralatrexate inhibits dihydrofolate reductase, an enzyme essential for DNA synthesis, thereby preventing cancer cell growth. Pembrolizumab is an immune checkpoint inhibitor that blocks the PD-1 receptor on T-cells, enhancing the immune system's ability to attack cancer cells. This dual approach of directly targeting cancer cell proliferation and boosting the body's immune response is crucial for effectively managing PTCL.

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,424 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,868 Previous Clinical Trials
41,010,824 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
~2 spots leftby Oct 2025