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
NCT ID: NCT04425070
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
56 participants
INTERVENTIONAL
2020-08-18
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ATG-010 + ICE
ATG-010 60 mg/once,total twice in each cycle; on Days 4 and 11
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).
ATG-010 + GEMOX
ATG-010 60 mg/once,total twice in each cycle; on Days 2 and 9
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).
ATG-010 + Tislelizumab
ATG 010 40mg/once, will be given on Days 1, 8, and 15 of each cycle
Tislelizumab
Tislelizumab will be administered intravenously at a fixed dose of 2 0 0 mg every 3 weeks on Day 1 of each cycle
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Antengene Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Yang Yu, MD
Role: STUDY_DIRECTOR
Medical Director
Locations
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Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Beijing Tongren Hospital.CMU
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Tianjin Medical Universisity Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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ATG-010-T/NK-001
Identifier Type: -
Identifier Source: org_study_id
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