NK/T-cell Lymphoma, Peripheral T-cell Lymphoma
Conditions
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.
Interventions
COMBINATION_PRODUCTICE [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).
COMBINATION_PRODUCTGEMOX [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).
COMBINATION_PRODUCTTislelizumab
Tislelizumab will be administered intravenously at a fixed dose of 2 0 0 mg every 3 weeks on Day 1 of each cycle
Sponsors
Antengene Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
ATG-010 + ICE ATG-010 + GEMOX ATG-010 + Tislelizumab
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient is willing to provide written ICF. 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
1. Current have disease or history of central nervous system lymphoma. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AEs/SAEs | 18 months | Toxicity will be graded according to the NCI CTCAE, Version 5.0. |
| Overall Response Rate (ORR) | 18 months | To determine the overall response rate according to Chenson 2014. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DOR) | 18 months | Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented. |
| Disease control rate (DCR) | 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) |
| Progression-free survival (PFS) | 18 months | Duration of time from the first dose of study drug until progression or death due to any cause |
| Overall Survival (OS) | 18 months | Duration of time from the first dose of study drug until death due to any cause |
Countries
China
Outcome results
None listed