Clinical trial NCT04425070: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Peripheral T-cell Lymphoma
NK/T-cell Lymphoma
Lead sponsor: Antengene Corporation
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ATG-010 + ICE ATG-010 + GEMOX ATG-010 + Tislelizumab
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. The patient is willing to provide written ICF.
2. Age≥ 18 years.
3. R/R PTCL and NK/T-cell lymphoma as confirmed by histological methods according to WHO classification of tumors of lymphoid tissues 2016.
4. Previously received at least one or more standard regimens including anthracycline.
5. Recurrence or the recurrence disease after the last treatment completed.
6. At least one measurable disease per modified efficacy assessment criteria (Cheson 2014).
7. ECOG PS 0 or 1.
8. 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.
9. Expected life time longer than 3 months.

Exclusion Criteria:

1. Current have disease or history of central nervous system lymphoma.
2. HBV-DNA positive, or HCV-RNA positive.
3. Patients with a known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome.
4. Received major surgery within 4 weeks of first dose of study drug
5. Known received SINE, including ATG-010.
6. Unable to swallow the tablets, suffers from malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may interfere with ATG-010 absorption.
7. Known allergy to ATG-010, or ICE, or GEMOX.
8. A woman who is pregnant or nursing.
9. The investigator considerations on patient's complications or other conditions may affect protocol compliance or may be inappropriate for participation in the study.

Primary outcomes:
measure: AEs/SAEs
timeFrame: 18 months
measure: Overall Response Rate (ORR)
timeFrame: 18 months
Secondary outcomes:
measure: Duration of response (DOR)
timeFrame: 18 months
measure: Disease control rate (DCR)
timeFrame: 4 weeks to 18 months
measure: Progression-free survival (PFS)
timeFrame: 18 months
measure: Overall Survival (OS)
timeFrame: 18 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Tongren Hospital.CMU
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical Universisity Cancer Institute & Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Medical Director
name: Yang Yu, MD
role: STUDY_DIRECTOR
References: