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

NCT ID: NCT06941688

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-13
• Study Completion Date: 2024-12-30

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Decatabine + GemOx (gemcitabine, oxaliplatin)

Group Type: EXPERIMENTAL

Decitabine with GemOx

Intervention Type: 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.

GemOx (gemcitabine, oxaliplatin)

Group Type: ACTIVE_COMPARATOR

GemOx

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

1. Diagnosis of a malignancy other than lymphoma within the past 3 years.

2. More than two prior lines of chemotherapy for lymphoma. Note: Autologous stem cell transplantation is considered part of one treatment regimen.

3. Evidence of uncontrolled central nervous system involvement.

4. History of solid organ or allogeneic stem cell transplantation.

5. Uncontrolled seizures or significant psychiatric disorders.

6. Pregnancy or breastfeeding.

7. Any other serious illness or medical condition deemed inappropriate by the investigator.

8. Presence of grade ≥2 peripheral neuropathy.

9. Prior treatment with gemcitabine for lymphoma.

10. History of HIV infection or active, uncontrolled bacterial, viral, or fungal infections.

11. Surgery within 14 days prior to enrollment, or failure to recover from surgical complications.

12. Patients currently receiving thoracic radiotherapy.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

YOUNGIL KOH

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1904-052-1027

Identifier Type: -

Identifier Source: org_study_id