Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas (NCT03598998)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (39 items) and avoid the listed exclusions (28 items).
Location: City of Hope Medical Center — Duarte, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patients with adult T-cell leukemia/lymphoma
- Prior allogeneic hematopoietic stem cell transplantation within the last 5 years.
- Prior autologous hematopoietic stem cell transplant within the last 60 days.
- 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.
- Patients who received prior therapy with pralatrexate without having had evidence of objective response.
- Investigational agent or anti-cancer monoclonal antibody (mAb) within 21 days prior to day 1 of therapy or who has not recovered (i.e. =\<1 or at baseline) from adverse events due to agents administered more than 21 days earlier.
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 14 days prior to day 1 of therapy or who has not recovered (i.e. =\< 1 or at baseline) from adverse events due to a previously administered agent. \* Note: Subjects with =\< grade 2 neuropathy are an exception and may qualify for the study.
- Antineoplastic biologic therapy or major surgery within 21 days of the first dose of trial medication. If subjects received major surgery more than 21 days ago, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Received live vaccine within 30 days prior to day 1 of protocol therapy.
- Systemic steroid therapy or on any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Diagnosis of immunodeficiency.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- City of Hope Medical Center — Duarte, California
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
- University of Nebraska Medical Center — Omaha, Nebraska
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.