- ICH GCP
- US Clinical Trials Registry
- 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 (TOUCH)
August 3, 2022 updated by: Antengene Corporation
A Single Arm, Open-label, and Multi-center Study to Evaluate the Safety and Primary Efficacy of ATG-010 Combined With Chemotherapy Sequential With ATG-010 Monotherapy Maintenance in Patients of Relapsed/Refractory Peripheral T- and NK/T-cell Lymphoma
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]), 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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
This trial is a single-arm, 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) sequential ATG 010 monotherapy maintenance, to evaluate the safety, tolerability, and primary efficacy in R/R PTCL and NK/T-cell lymphoma patients.
Fifty patients are planned to be enrolled.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sunny He, M.D.
- Phone Number: 13701803117
- Email: sunny.he@antengene.com
Study Contact Backup
- Name: Dahang Xue
- Phone Number: 18500533744
- Email: dahang.xue@antengene.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100191
- Recruiting
- Peking University Third Hospital
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-Sen University Cancer Center
-
Contact:
- Huiqiang Huang
-
-
Henan
-
Zhengzhou, Henan, China, 450008
- Recruiting
- Henan Cancer Hospital
-
-
Hubei
-
Wuhan, Hubei, China, 430079
- Recruiting
- Hubei Cancer Hospital
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210000
- Recruiting
- Jiangsu Cancer Hospital
-
Contact:
- Jianqiu Wu
-
Nanjing, Jiangsu, China, 210029
- Recruiting
- Jiangsu Province Hospital
-
Contact:
- Lei Fan
-
-
Jilin
-
Changchun, Jilin, China
- Recruiting
- Jilin cancer hospital
-
-
Tianjin
-
Tianjin, Tianjin, China, 300060
- Recruiting
- Tianjin Medical Universisity Cancer Institute & Hospital
-
Contact:
- Huilai Zhang
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310003
- Recruiting
- The First Affiliated Hospital, Zhejiang University School of Medicine
-
Contact:
- Zhen Cai
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ATG-010 + ICE
ATG-010 60 mg/once,total twice in each cycle; on Days 4 and 11
|
• Combined with ICE chemotherapy regimen:
|
Experimental: ATG-010 + GEMOX
ATG-010 60 mg/once,total twice in each cycle; on Days 2 and 9
|
• Combined with GEMOX chemotherapy regimen:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AEs/SAEs
Time Frame: 18 months
|
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
|
18 months
|
Overall Response Rate (ORR)
Time Frame: 18 months
|
To determine the overall response rate according to Chenson 2014.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of response (DOR)
Time Frame: 18 months
|
Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented.
|
18 months
|
Disease control rate (DCR)
Time Frame: 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)
|
4 weeks to 18 months
|
Progression-free survival (PFS)
Time Frame: 18 months
|
Duration of time from the first dose of study drug until progression or death due to any cause
|
18 months
|
Overall Survival (OS)
Time Frame: 18 months
|
Duration of time from the first dose of study drug until death due to any cause
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sai Lou, MD, Medical Director
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 18, 2020
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
May 25, 2020
First Submitted That Met QC Criteria
June 9, 2020
First Posted (Actual)
June 11, 2020
Study Record Updates
Last Update Posted (Actual)
August 5, 2022
Last Update Submitted That Met QC Criteria
August 3, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Gemcitabine
- Carboplatin
- Etoposide
- Oxaliplatin
- Ifosfamide
Other Study ID Numbers
- ATG-010-T/NK-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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