Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma
Plain-language summary
This trial is testing a hypomethylating agent (azacitidine or decitabine) based regimen for patients with cutaneous T-cell lymphoma (CTCL), including mycosis fungoides or Sézary syndrome who have been newly diagnosed and have not yet received treatment as well as those whose disease has come back or stopped responding to prior treatment. This is a Phase 1/2 trial, which means researchers are determining the best dose and getting early information about effectiveness. Patients are randomly assigned to different treatment groups. This trial is available at 1 location in the United States. The trial is currently recruiting patients.
Who can join (key eligibility)
- Age 18 Years or older
- Newly diagnosed, not yet treated
- Must be well enough for treatment (adequate performance status)
Final eligibility is determined by the trial team. This list is a starting point only.
What's being tested
Durvalumab (DRUG): Durvalumab is an investigational human monoclonal antibody that works to inhibit (block) a protein called programmed cell death-1 ligand 1 (PD-L1). Durvalumab has not been approved by the FDA for the treatment of PTCL but has been given to patients other types of cancers. Given intravenously (through the vein). Starting dose: 1500 mg | Pralatrexate (DRUG): Pralatrexate is an antimetabolite drug. Pralatrexate alone is FDA-approved for the treatment of PTCL. Given intravenously (through the vein). Starting dose: 25 mg/m2 | Romidepsin (DRUG): Romidepsin is another type of chemotherapy known as histone deacetylase (HDAC) inhibitors. Romidepsin has not been approved for use in lymphoma other than Cutaneous T cell lymphoma (CTCL) by the FDA. Given intravenously (through the vein). Starting dose: 12 mg/m2 | 5-Azacitidine (DRUG): Oral 5-azacitidine is used for the treatment of myelodysplastic syndrome and acute myeloid leukemia. Azacitidine prevents the body from making DNA and RNA that cells need to grow. This stops the growth of cancer cells and causes them to die. Given by mouth (orally). Starting dose: 300 mg daily
Durvalumab, Pralatrexate, Romidepsin, 5-Azacitidine
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details