Evaluating the Effectiveness of Decitabine With Gemcitabine, Oxaliplatin for Relapsed/Refractory Peripheral T-cell Lymphoma

Inclusion Criteria

• •Patients must meet all of the following criteria to be considered eligible.
• •1. Patients with histologically confirmed peripheral T-cell lymphoma (PTCL) who have either relapsed after first-line chemotherapy or experienced disease progression due to refractory disease, and who are deemed eligible for further chemotherapy.
• •2. Age ≥ 19 years.
• •3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• •4. Adequate bone marrow function, defined as:
• •1. White blood cell count ≥ 3,000/μL
• •2. Absolute neutrophil count ≥ 2,000/μL
• •3. Platelet count ≥ 75,000/μL
• •4. Hemoglobin ≥ 8.0 g/dL Note: Transfusions within 1 week prior to screening are not permitted.
• •5. Adequate renal function, defined as serum creatinine ≤ 1.5 × upper limit of normal (ULN).
• •6. Adequate hepatic function, defined as:
• •1. Serum total bilirubin ≤ 1.5 × ULN
• •2. AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN (or ≤ 5 × ULN in the presence of liver metastases) Note: Patients with hepatic dysfunction due to underlying disease may be enrolled at the investigator's discretion.
• •7. Presence of measurable disease.
• •8. Ability to understand and provide written informed consent.
• •9. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
• •10. Female patients of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) test within 3 weeks prior to treatment, and must agree to use effective contraception (e.g., barrier methods) from 4 weeks prior to treatment initiation through the study duration.
• •1. Diagnosis of a malignancy other than lymphoma within the past 3 years.
• •2. More than two prior lines of chemotherapy for lymphoma. Note: Autologous stem cell transplantation is considered part of one treatment regimen.
• •3. Evidence of uncontrolled central nervous system involvement.
• •4. History of solid organ or allogeneic stem cell transplantation.
• •5. Uncontrolled seizures or significant psychiatric disorders.
• •6. Pregnancy or breastfeeding.
• •7. Any other serious illness or medical condition deemed inappropriate by the investigator.
• •8. Presence of grade ≥2 peripheral neuropathy.
• •9. Prior treatment with gemcitabine for lymphoma.
• •10. History of HIV infection or active, uncontrolled bacterial, viral, or fungal infections.
• •11. Surgery within 14 days prior to enrollment, or failure to recover from surgical complications.
• •12. Patients currently receiving thoracic radiotherapy.