Natural Killer T-cell Lymphoma
Conditions
Brief summary
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of golidocitinib and benmelstobart combination treatment in patients with relapsed or refractory extranodal natural killer/T cell lymphoma.
Interventions
DRUGGolidocitinib
150 mg, administered once daily from Day 1 to Day 21 (D1-D21)
DRUGBenmelstobart
1200 mg, administered on Day 1 (D1) of every cycle
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects fully understand and voluntarily participate in this study and sign informed consent. 2. Pathologically confirmed extranodal natural killer/T cell lymphoma (ENKTL). 3. Age ≥18, no gender limitation. 4. Treatment failure to at least one line of asparaginase-based therapy. 5. Eastern Cooperative Oncology Group performance status of 0-2 6. Expected survival ≥ 3 months. 7. At least one measurable lesion that meets Lugano 2014 criteria. 8. Sufficient organ function.
Exclusion criteria
1. Invasive NK-cell leukemia or NKTCL that has progressed to leukemia. 2. Accompanied by hemophagocytic lymphohistiocytosis. 3. NKTCL with central nervous system invasion. 4. Previously treated with JAK inhibitors. 5. The patients have contraindications to any drug in the combined treatment. 6. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome. 7. Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug. 8. Pregnant and lactating women and subjects of childbearing age who do not want to use contraception. 9. Mentally ill persons or persons unable to obtain informed consent. The investigators think that the patient is not suitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate(ORR) | 2 years | The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response(CR) | 2 years | Defined as the proportion of patients who achieve complete remission as the best response |
| Duration of Response(DOR) | Up to 4 years | To investigate the preliminary anti-tumor efficacy |
| Progression-free survival(PFS) | Up to 4 years | To investigate the preliminary anti-tumor efficacy |
| Overall survival(OS) | Up to 4 years | To investigate the preliminary anti-tumor efficacy |
| Incidence and severity of adverse events (AE) , Serious adverse event (SAE) and immune-related adverse event (irAE) | Through study completion, up tp 2 years. | To identify the incidence of AE, SAE, and irAE. |
Countries
China
Contacts
Primary ContactQingqing Cai, MD. PhD.
Outcome results
None listed