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Pembrolizumab + Pralatrexate for Peripheral T-Cell Lymphoma
Study Summary
This trial is studying pralatrexate and pembrolizumab to see how well they work in treating patients with peripheral T-cell lymphomas.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- Your kidneys can clean at least 60 milliliters of blood per minute based on a specific formula.I have adult T-cell leukemia/lymphoma.I was treated with specific immune therapies but did not respond.My lymphoma diagnosis is confirmed and matches WHO's classification.I have received a vitamin B12 shot and started folic acid before starting pralatrexate.I have active hepatitis B or C.I have had tuberculosis in the past.My blood clotting time is within the target range for my blood thinner medication.My blood clotting time is within the target range for my anticoagulant therapy.I have an autoimmune disease treated with medication in the last 2 years.I have been diagnosed with HIV.I have an infection that needs treatment with medication.Your bilirubin levels in the blood are not too high.Your AST level in the blood is not more than 2.5 times the normal limit.I haven't had cancer drug therapy or major surgery in the last 3 weeks.I am a woman who can have children and have a negative pregnancy test.I am using two birth control methods or am not having sex to join this study.I had a stem cell transplant from a donor within the last 5 years.I had a stem cell transplant using my own cells within the last 2 months.I have not received a live vaccine in the last 30 days.I took pralatrexate before but it didn't shrink my cancer.I haven't taken any experimental cancer drugs or antibodies in the last 21 days.I haven't had cancer treatment or recovered from its side effects in the last 14 days.I haven't taken steroids or immunosuppressants in the last 7 days.I have been diagnosed with an immune system disorder.I have severe limitations due to heart failure.I don't have any health issues that could affect the trial's results.My white blood cell count is within the required range for the study.I am willing and able to sign the consent form myself or have someone legally authorized to do so on my behalf.My cancer returned or worsened after at least one treatment.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.My blood clotting time is near normal and I'm not on blood thinners.I will use two forms of birth control or abstain from sex during and for 120 days after my treatment.My lymphoma has spread to my brain or spinal cord.I agree to provide a new or previous biopsy sample for the study.I am not pregnant or breastfeeding.I have had pneumonitis treated with steroids or have it now.I have a tumor that is larger than 1.5cm, confirmed by CT or PET scan.I am fully active or restricted in physically strenuous activity but can do light work.You have had a bad allergic reaction to pembrolizumab, pralatrexate, leucovorin, or any of the other ingredients in the medications.Your alanine aminotransferase (ALT) level should be less than or equal to 2.5 times the upper limit of normal (ULN).I have another cancer that is getting worse or needs treatment.My blood clotting time is within normal limits.
- Group 1: Treatment (pralatrexate and pembrolizumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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