Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell… (NCT03598998) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
United States13 participantsStarted 2019-02-04
Plain-language summary
This phase I/II trial studies the side effects and best dose of pralatrexate when given together with pembrolizumab and how well they work in treating patients with peripheral T-cell lymphomas that has come back after a period of improvement or has not responded to treatment. Pralatrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab and pralatrexate may work better in treating patients with peripheral T-cell lymphomas.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented willingness and ability to sign an informed consent of the participant and/or legally authorized representative.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* 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. Eligible histologies are:
* Peripheral T-cell lymphoma, not otherwise specified
* Anaplastic large cell lymphoma, ALK-negative
* Anaplastic large cell lymphoma, ALK-positive
* Angioimmunoblastic T-cell lymphoma
* Nodal peripheral T-cell lymphoma with TFH phenotype
* Follicular T-cell lymphoma
* Indolent T-cell lymphoproliferative disorder of the gastrointestinal (GI) tract
* Extranodal NK-/T-cell lymphoma
* Enteropathy-associated T cell lymphoma
* Monomorphic epitheliotropic intestinal T-cell lymphoma
* Hepatosplenic T-cell lymphoma
* Subcutaneous panniculitis-like T-cell lymphoma
* Transformed mycosis fungoides
* Patients must have failed at least one prior regimen, including:
* Recurrence of disease after a documented complete response (CR).
* Progression of disease after a partial response (PR) to the prior regimen.
* Partial response, stable disease (SD) or progressive disease (PD) at the completion of the prior treatment regimen. If a patient has PR to prior regimen without P…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Had Dose Limiting Toxicities
Timeframe: From the start of Cycle 1 through the start of Cycle 3 (approximately 42 days)
2
Number of Participants Who Had Overall Response
Timeframe: Up to 43 months after the initial study treatment.