Plain-language summary

This Phase 1, Phase 2 trial is comparing different first-line treatment approaches for people newly diagnosed with cutaneous T-cell lymphoma (skin lymphoma). Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 1 US location.

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

Drugs / treatments

Durvalumab, Pralatrexate, Romidepsin, 5-Azacitidine

Treatment length

Ask the trial team for details

Visit frequency

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