A Phase 1/2, Open-label, Multi-center Study to Evaluate theSafety and Efficacy of Selinexor Combined With Chemotherapy orTislelizumab in Relapsed or Refractory Mature T and NK Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 56
- 试验地点
- 21
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •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.
排除标准
- •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-
- •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.
研究组 & 干预措施
ATG-010 + ICE
ATG-010 60 mg/once,total twice in each cycle; on Days 4 and 11
干预措施: ICE [ifosfamide+carboplatin+etoposide] (Combination Product)
ATG-010 + GEMOX
ATG-010 60 mg/once,total twice in each cycle; on Days 2 and 9
干预措施: GEMOX [gemcitabine+oxaliplatin] (Combination Product)
ATG-010 + Tislelizumab
ATG 010 40mg/once, will be given on Days 1, 8, and 15 of each cycle
干预措施: Tislelizumab (Combination Product)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 18 months
To determine the overall response rate according to Chenson 2014.
AEs/SAEs
时间窗: 18 months
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
次要结局
- Progression-free survival (PFS)(18 months)
- Disease control rate (DCR)(4 weeks to 18 months)
- Duration of response (DOR)(18 months)
- Overall Survival (OS)(18 months)