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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

August 18, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Peripheral T-cell LymphomaNK/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

Trial Locations (13)

100005

Beijing Tongren Hospital.CMU, Beijing

100191

Peking University Third Hospital, Beijing

200032

Fudan University Shanghai Cancer Center, Shanghai

210000

Jiangsu Cancer Hospital, Nanjing

210029

Jiangsu Province Hospital, Nanjing

230031

Anhui Provincial Cancer Hospital, Hefei

300060

Tianjin Medical Universisity Cancer Institute & Hospital, Tianjin

310003

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

400030

Chongqing University Cancer Hospital, Chongqing

430079

Hubei Cancer Hospital, Wuhan

450008

Henan Cancer Hospital, Zhengzhou

510060

Sun Yat-sen University Cancer Center, Guangzhou

530021

Guangxi Medical University Cancer Hospital, Nanning

All Listed Sponsors
lead

Antengene Corporation

INDUSTRY