Back to resultsA 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 (TOUCH)
Primary Purpose
Peripheral T-cell Lymphoma, NK/T-cell Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ICE [ifosfamide+carboplatin+etoposide]
GEMOX [gemcitabine+oxaliplatin]
Tislelizumab
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral T-cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Anhui Provincial Cancer Hospital
- Beijing Tongren Hospital.CMU
- Peking University Third Hospital
- Chongqing University Cancer Hospital
- Sun Yat-sen University Cancer CenterRecruiting
- Guangxi Medical University Cancer Hospital
- Henan Cancer Hospital
- Hubei Cancer Hospital
- Jiangsu Cancer Hospital
- Jiangsu Province Hospital
- Jilin Cancer Hospital
- Fudan University Shanghai Cancer CenterRecruiting
- Tianjin Medical Universisity Cancer Institute & Hospital
- The First Affiliated Hospital, Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
ATG-010 + ICE
ATG-010 + GEMOX
ATG-010 + Tislelizumab
Arm Description
ATG-010 60 mg/once,total twice in each cycle; on Days 4 and 11
ATG-010 60 mg/once,total twice in each cycle; on Days 2 and 9
ATG 010 40mg/once, will be given on Days 1, 8, and 15 of each cycle
Outcomes
Primary Outcome Measures
AEs/SAEs
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
Overall Response Rate (ORR)
To determine the overall response rate according to Chenson 2014.
Secondary Outcome Measures
Duration of response (DOR)
Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented.
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)
Progression-free survival (PFS)
Duration of time from the first dose of study drug until progression or death due to any cause
Overall Survival (OS)
Duration of time from the first dose of study drug until death due to any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04425070
Brief Title
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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antengene Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-cell Lymphoma, NK/T-cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
ATG-010 + ICE ATG-010 + GEMOX ATG-010 + Tislelizumab
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
97 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ATG-010 + ICE
Arm Type
Experimental
Arm Description
ATG-010 60 mg/once,total twice in each cycle; on Days 4 and 11
Arm Title
ATG-010 + GEMOX
Arm Type
Experimental
Arm Description
ATG-010 60 mg/once,total twice in each cycle; on Days 2 and 9
Arm Title
ATG-010 + Tislelizumab
Arm Type
Experimental
Arm Description
ATG 010 40mg/once, will be given on Days 1, 8, and 15 of each cycle
Intervention Type
Combination Product
Intervention Name(s)
ICE [ifosfamide+carboplatin+etoposide]
Intervention Description
• 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).
Intervention Type
Combination Product
Intervention Name(s)
GEMOX [gemcitabine+oxaliplatin]
Intervention Description
• 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).
Intervention Type
Combination Product
Intervention Name(s)
Tislelizumab
Intervention Description
Tislelizumab will be administered intravenously at a fixed dose of 2 0 0 mg every 3 weeks on Day 1 of each cycle
Primary Outcome Measure Information:
Title
AEs/SAEs
Description
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
Time Frame
18 months
Title
Overall Response Rate (ORR)
Description
To determine the overall response rate according to Chenson 2014.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Duration of response (DOR)
Description
Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented.
Time Frame
18 months
Title
Disease control rate (DCR)
Description
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)
Time Frame
4 weeks to 18 months
Title
Progression-free survival (PFS)
Description
Duration of time from the first dose of study drug until progression or death due to any cause
Time Frame
18 months
Title
Overall Survival (OS)
Description
Duration of time from the first dose of study drug until death due to any cause
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sunny He, M.D.
Phone
13701803117
Email
sunny.he@antengene.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Wang
Phone
17601350610
Email
sara.wang@antengene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sai Lou, MD
Organizational Affiliation
Medical Director
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yang Yu, MD
Organizational Affiliation
Medical Director
Official's Role
Study Director
Facility Information:
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Individual Site Status
Suspended
Facility Name
Beijing Tongren Hospital.CMU
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Suspended
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Suspended
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Suspended
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiqiang Huang, PhD
Facility Name
Guangxi Medical University Cancer Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Suspended
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Suspended
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Suspended
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Suspended
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Suspended
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Withdrawn
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Wang, CTM
First Name & Middle Initial & Last Name & Degree
Rong Tao, PhD
Facility Name
Tianjin Medical Universisity Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Suspended
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Suspended
12. IPD Sharing Statement
Learn more about this trial
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
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