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
- Conditions
- NK/T-cell LymphomaPeripheral T-cell Lymphoma
- Interventions
- Combination Product: ICE [ifosfamide+carboplatin+etoposide]Combination Product: GEMOX [gemcitabine+oxaliplatin]Combination Product: Tislelizumab
- Registration Number
- NCT04425070
- Lead Sponsor
- Antengene Corporation
- Brief 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.
- Detailed Description
This trial is an open-label, multi-center Phase Ib clinical study that will evaluate ATG-010 combined with chemotherapy regimen selected by investigators (ICE regimen ifosfamide+carboplatin+etoposide; Or GEMOX regimen: gemcitabine+oxaliplatin; Tislelizumab) sequential ATG 010 monotherapy maintenance, to evaluate the safety, tolerability, and primary efficacy in R/R PTCL and NK/T-cell lymphoma patients. 97 patients are planned to be enrolled.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 56
- The patient is willing to provide written ICF.
- Age≥ 18 years.
- R/R PTCL and NK/T-cell lymphoma as confirmed by histological methods according to WHO classification of tumors of lymphoid tissues 2016.
- Previously received at least one or more standard regimens including anthracycline.
- Recurrence or the recurrence disease after the last treatment completed.
- At least one measurable disease per modified efficacy assessment criteria (Cheson 2014).
- ECOG PS 0 or 1.
- Any toxicity caused by previously anti-tumor therapy must recovered to ≤ Grade 1 (NCI-CTCAE v5.0) with exception of hearing loss, alopecia, and pigmentation.
- Expected life time longer than 3 months.
- Current have disease or history of central nervous system lymphoma.
- HBV-DNA positive, or HCV-RNA positive.
- Patients with a known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome.
- Received major surgery within 4 weeks of first dose of study drug
- Known received SINE, including ATG-010.
- Unable to swallow the tablets, suffers from malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may interfere with ATG-010 absorption.
- Known allergy to ATG-010, or ICE, or GEMOX.
- A woman who is pregnant or nursing.
- The investigator considerations on patient's complications or other conditions may affect protocol compliance or may be inappropriate for participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ATG-010 + ICE ICE [ifosfamide+carboplatin+etoposide] ATG-010 60 mg/once,total twice in each cycle; on Days 4 and 11 ATG-010 + GEMOX GEMOX [gemcitabine+oxaliplatin] ATG-010 60 mg/once,total twice in each cycle; on Days 2 and 9 ATG-010 + Tislelizumab Tislelizumab ATG 010 40mg/once, will be given on Days 1, 8, and 15 of each cycle
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) 18 months To determine the overall response rate according to Chenson 2014.
AEs/SAEs 18 months Toxicity will be graded according to the NCI CTCAE, Version 5.0.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) 18 months Duration of time from the first dose of study drug until death due to any cause
Progression-free survival (PFS) 18 months Duration of time from the first dose of study drug until progression or death due to any cause
Disease control rate (DCR) 4 weeks to 18 months Proportion of patients who achieve CR, PR, or SD for a minimum of 4 weeks, following the first dose of study drug (i.e., CR+PR+SD)
Duration of response (DOR) 18 months Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented.
Trial Locations
- Locations (13)
Guangxi Medical University Cancer Hospital
🇨🇳Nanning, Guangxi, China
Anhui Provincial Cancer Hospital
🇨🇳Hefei, Anhui, China
Beijing Tongren Hospital.CMU
🇨🇳Beijing, Beijing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Tianjin Medical Universisity Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China