Status:
TERMINATED
Evaluating the Effectiveness of Decitabine With Gemcitabine, Oxaliplatin for Relapsed/Refractory Peripheral T-cell Lymphoma
Lead Sponsor:
Seoul National University Hospital
Conditions:
Peripheral T-cell Lymphoma (PTCL)
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
To establish an optimal therapeutic strategy for patients with peripheral T-cell lymphoma (PTCL) who have relapsed after first-line chemotherapy or are refractory to initial treatment, we designed a p...
Eligibility Criteria
Inclusion
- Patients must meet all of the following criteria to be considered eligible.
- 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.
- Age ≥ 19 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Adequate bone marrow function, defined as:
- White blood cell count ≥ 3,000/μL
- Absolute neutrophil count ≥ 2,000/μL
- Platelet count ≥ 75,000/μL
- Hemoglobin ≥ 8.0 g/dL Note: Transfusions within 1 week prior to screening are not permitted.
- Adequate renal function, defined as serum creatinine ≤ 1.5 × upper limit of normal (ULN).
- Adequate hepatic function, defined as:
- Serum total bilirubin ≤ 1.5 × ULN
- 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.
- Presence of measurable disease.
- Ability to understand and provide written informed consent.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- 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.
Exclusion
- Patients will be deemed ineligible if they meet any of the exclusion criteria listed below.
- Diagnosis of a malignancy other than lymphoma within the past 3 years.
- More than two prior lines of chemotherapy for lymphoma. Note: Autologous stem cell transplantation is considered part of one treatment regimen.
- Evidence of uncontrolled central nervous system involvement.
- History of solid organ or allogeneic stem cell transplantation.
- Uncontrolled seizures or significant psychiatric disorders.
- Pregnancy or breastfeeding.
- Any other serious illness or medical condition deemed inappropriate by the investigator.
- Presence of grade ≥2 peripheral neuropathy.
- Prior treatment with gemcitabine for lymphoma.
- History of HIV infection or active, uncontrolled bacterial, viral, or fungal infections.
- Surgery within 14 days prior to enrollment, or failure to recover from surgical complications.
- Patients currently receiving thoracic radiotherapy.
Key Trial Info
Start Date :
November 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT06941688
Start Date
November 13 2020
End Date
December 30 2024
Last Update
April 24 2025
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea