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

Peripheral T-cell Lymphoma Clinical Trial

— TOUCH  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04425070
• Other study ID #: ATG-010-T/NK-001
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: August 18, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Antengene Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tongren Hospital.CMU	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Chongqing University Cancer Hospital	Chongqing	Chongqing
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Anhui Provincial Cancer Hospital	Hefei	Anhui
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Guangxi Medical University Cancer Hospital	Nanning	Guangxi
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Tianjin Medical Universisity Cancer Institute & Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Antengene Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs/SAEs	Toxicity will be graded according to the NCI CTCAE, Version 5.0.	18 months
Primary	Overall Response Rate (ORR)	To determine the overall response rate according to Chenson 2014.	18 months
Secondary	Duration of response (DOR)	Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented.	18 months
Secondary	Disease control rate (DCR)	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)	4 weeks to 18 months
Secondary	Progression-free survival (PFS)	Duration of time from the first dose of study drug until progression or death due to any cause	18 months
Secondary	Overall Survival (OS)	Duration of time from the first dose of study drug until death due to any cause	18 months