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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
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.
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.
Seoul National University Hospital
Seoul, South Korea
Objective response rate
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.
Time frame: From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days)
Complete response (CR) rate
Time frame: From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days)
Time to response (TTR)
Time frame: From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days)
Progression-free survival (PFS)
Time frame: From cycle 1 day 1 to study completion, an average of 2 years.
Overall survival (OS)
Time frame: From cycle 1 day 1 to study completion, an average of 2 years.
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