Study on Tolinapant with Oral Decitabine/Cedazuridine for Treating Relapsed or Refractory Peripheral T-cell Lymphoma

Inclusion Criteria

• Life expectancy of more than 12 weeks.
• Confirmed diagnosis of relapsed or refractory Peripheral T-cell Lymphoma (R/R PTCL) based on specific medical criteria.
• Eligible subtypes include various forms of T-cell lymphoma such as Extranodal NK/T-cell lymphoma, Enteropathy-associated T-cell lymphoma, and others.
• Must have progressive disease and have tried at least two previous treatments.
• Must have measurable disease with tumors of a certain size visible on scans.
• If the disease is CD30-positive, must have tried or be unable to take brentuximab vedotin.
• Good overall health with a performance status score of 0, 1, or 2.
• Acceptable organ function based on specific medical tests.
• Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study.

Exclusion Criteria

• Previous treatment with Tolinapant or similar drugs.
• Allergies to Tolinapant or Decitabine/Cedazuridine.
• Poor health due to other serious diseases or conditions.
• Serious heart conditions or risks, such as heart failure or abnormal heart rhythms.
• Active infections like HIV, hepatitis B, or hepatitis C.
• Severe nerve damage.
• Significant mental health issues or substance abuse problems.
• Recent cancer treatments within specific time frames before starting the study.
• Other active cancers requiring treatment, except certain stable cancers.
• Known brain lymphoma.
• Recent organ transplants or certain immune therapies.
• Use of certain medications or vaccines close to the start of the study.