A Study of Evaluating the Safety and Efficacy of ATG-010 Combined With Chemotherapy Sequential Wi… (NCT04425070) | Clinical Trial Compass
TerminatedPhase 1/2
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
Stopped: Based on the adjustment of clinical research and development strategy，sponsor decided to terminate the study
China56 participantsStarted 2020-08-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
Exclusion criteria
✕. Current have disease or history of central nervous system lymphoma.
✕. 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.