MedTrace Logo

A Study of Evaluating the Safety and Efficacy of ATG-010 Combined With Chemotherapy Sequential With ATG-010 Monotherapy Maintenance in Peripheral T- and NK/T-cell Lymphoma

NCT04425070 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-01-05

No results posted yet for this study

Summary

This trial is proposed with treatment of ATG-010 combined with chemotherapy regimens which will be chosen by investigators (ICE \[ifosfamide+carboplatin+etoposide\] or GEMOX \[gemcitabine+oxaliplatin\] or Tislelizumab), after treatments of 2 to 6 cycles transferring to ATG-010 monotherapy maintenance treatment, to evaluate the safety, tolerability, and primary efficacy of ATG-010 in R/R PTCL and NK/T-cell lymphoma patients.

Conditions

  • Peripheral T-cell Lymphoma
  • NK/T-cell Lymphoma

Interventions

COMBINATION_PRODUCT

ICE [ifosfamide+carboplatin+etoposide]

• Combined with ICE chemotherapy regimen: * Ifosfamide: 5 g/m2, continuous intravenous (iv) infusion (mesna 5 g/m2 synchronously iv infusion for rescue), on Day 2; * Carboplatin: with concentration-area under time curve (AUC)=5 (highest concentration to 800 mg), iv infusion, on Day 2; * Etoposide l00 mg/m2, iv infusion, on Days 1-3; * ATG-010 60 mg/once, oral, on Days 4 and 11. After the treatment with combination chemotherapy, the patients will continue to receive maintenance treatment of ATG-010 60 mg/once per week (QW).

COMBINATION_PRODUCT

GEMOX [gemcitabine+oxaliplatin]

• Combined with GEMOX chemotherapy regimen: * Gemcitabine 1000 mg/m2, iv infusion, on Days 1 and 8; * Oxaliplatin 130 mg/m2, iv infusion, on Day 1; * ATG-010 60 mg/once, oral, on Days 2 and 9. After the treatment with combination chemotherapy, the patients will continue to receive maintenance treatment of ATG-010 60 mg/once per week (QW).

COMBINATION_PRODUCT

Tislelizumab

Tislelizumab will be administered intravenously at a fixed dose of 2 0 0 mg every 3 weeks on Day 1 of each cycle

Sponsors & Collaborators

  • Antengene Corporation

    lead INDUSTRY

Principal Investigators

  • Yang Yu, MD · Medical Director

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • China

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 NCT04425070 on ClinicalTrials.gov