MedTrace Logo

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

NCT06941688 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-04-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-13
Primary Completion
2024-08-13
Completion
2024-12-30

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06941688 on ClinicalTrials.gov