Study for Patients with Peripheral T-Cell Lymphoma (PTCL) or Cutaneous T-Cell Lymphoma (CTCL) Comparing an Investigational Combination of Pembrolizumab (Keytruda) with Decitabine and/or Pralatrexate (PTCL 002)

The University of Virginia Cancer Center is conducting a clinical research study for patients who are adults with peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL) who have received treatment but the treatment either didn’t work or stopped working. The purpose of this study is to better understand the safety and efficacy of the combinations of pembrolizumab with decitabine, pralatrexate, or both decitabine and pralatrexate.

Pralatrexate is approved for treating patients with PTCL and CTCL, and pembrolizumab and decitabine have been approved in other types of cancer, but not in PTCL or CTCL, so these combinations are investigational but the safety profiles of all of the drugs are well known. Investigators think that adding pralatrexate and/or decitabine to pembrolizumab may increase people’s immune response in fighting the cancer. Pembrolizumab has shown significant activity in patients with PTCL and CTCL. Participants will be assigned treatment based on the order they come into the study; participants will not get to choose.

Participants will receive intravenous pembrolizumab every 3 weeks, participants that receive intravenous pralatrexate will receive it weekly for the first 3 weeks of each 28-day cycle, and participants that receive intravenous decitabine will receive it on days 1 through 5 of each 28-day cycle. If participants have significant side effects, frequency and/or dose of one or more of the drugs may be decreased.

All participants will receive treatment for as long as the treatment is working for them and have research samples collected before, during, and after study treatment is completed. This duration will vary among participants. Participants will still be followed even after they have completed the study treatment. Study-specific tests that are being done beyond standard of care will be provided at no cost to the patient/participant or his/her/their insurance.

Additional information can be found here: PTCL 002 - clinicaltrials.gov