Peripheral T-cell Lymphoma (PTCL)
Conditions
Keywords
PTCL, Decitabine, GemOx, Randomized Phase II trial
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 phase II trial to evaluate the efficacy of a multidrug combination regimen comprising decitabine, gemcitabine, and oxaliplatin as a second-line or later treatment. This clinical trial is based on a review of existing literature, which supports the rationale for using this three-drug combination.
Interventions
DRUGDecitabine with GemOx
Each treatment cycle consists of 3 weeks, and a total of 6 cycles will be administered. The drugs will be administered sequentially in the following order: decitabine, gemcitabine, and oxaliplatin. Decitabine will be administered at a dose of 7.5 mg/m² on days 1 to 5; gemcitabine at 1000 mg/m² on days 1 and 8; and oxaliplatin at 100 mg/m² on day 1 of each cycle.
DRUGGemOx
Each treatment cycle spans 3 weeks, with a total of 6 cycles planned. Gemcitabine will be administered at a dose of 1000 mg/m² on days 1 and 8, and oxaliplatin at 100 mg/m² on day 1 of each cycle.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
* Patients will be deemed ineligible if they meet any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days) | The objective response rate (ORR) is defined as the proportion of patients who achieve either a complete response (CR) or a partial response (PR) to treatment, as assessed by Lugano criteria. |
Secondary
| Measure | Time frame |
|---|---|
| Complete response (CR) rate | From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days) |
| Time to response (TTR) | From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days) |
| Progression-free survival (PFS) | From cycle 1 day 1 to study completion, an average of 2 years. |
| Overall survival (OS) | From cycle 1 day 1 to study completion, an average of 2 years. |
Countries
South Korea
Outcome results
None listed