Status:
TERMINATED
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
Lead Sponsor:
Antengene Corporation
Conditions:
Peripheral T-cell Lymphoma
NK/T-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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\...
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;...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04425070
Start Date
August 18 2020
End Date
December 30 2025
Last Update
January 5 2026
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230031
2
Beijing Tongren Hospital.CMU
Beijing, Beijing Municipality, China, 100005
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
4
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030