NCT06941688

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

Phase II, Multicentre, Randomized Study of Decitabine Plus GemOx Versus GemOx for Relapsed/Refractory Peripheral T-cell Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral T-cell Lymphoma (PTCL)

Interventions

Type	Name	Description
DRUG	Decitabine 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.
DRUG	GemOx	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.

Timeline

• Start date: 2020-11-13
• Primary completion: 2024-08-13
• Completion: 2024-12-30
• First posted: 2025-04-24
• Last updated: 2025-04-24

Locations

1 site across 1 country: South Korea