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

NCT06941688 | Terminated Phase 2

• 1 other identifier: 1904-052-1027
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral T-cell Lymphoma (PTCL)

Keywords

PTCL; Decitabine; GemOx; Randomized Phase II trial

Outcome Measures

Primary Outcomes (1)

• 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.

  From cycle 1 day 1 to completion of cycle 6 (each cycle is 21 days)

Secondary Outcomes (4)

• 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.

Study Arms (2)

Decatabine + GemOx (gemcitabine, oxaliplatin)

EXPERIMENTAL

Drug: Decitabine with GemOx

GemOx (gemcitabine, oxaliplatin)

ACTIVE COMPARATOR

Drug: GemOx

Interventions

Decitabine with GemOx DRUG

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.

Decatabine + GemOx (gemcitabine, oxaliplatin)

GemOx DRUG

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.

GemOx (gemcitabine, oxaliplatin)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 24, 2025
• Study Start: November 13, 2020
• Primary Completion: August 13, 2024
• Study Completion: December 30, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)