Extranodal NK/T Cell Lymphoma, Nasal Type
Conditions
Keywords
ENKTL
Brief summary
The purpose of this study is to evaluate the safety and efficacy of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type).
Interventions
DRUGIBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)
IBI318, 300mg, Q2W, Intravenous influsion.
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically diagnosed as extra-nodal NK/T cell lymphoma (nasal type) according to WHO 2016 criteria; 2. Refractory and relapsed ENKTL patients, being relapsed is defined as re-occurrence of the same lymphoma lesions at the primary site or new sites after complete response (CR); being refractory is defined as having any of the following conditions: evaluated as stable disease (SD) or progression disease (PD) after 2 cycles of treatment; not being able to achieve partial response (PR) after 4 cycles of treatment; not being able to achieve complete response (CR) after 6 cycles of treatment. Patients that did not achieve remission, or relapsed/progressed after autologous stem cell transplantation (ASCT) could also be enrolled. 3. Patients must have received asparaginase-based chemotherapy previously (patients with phase I/II disease must have received radiotherapy previously). 4. With measurable foci, defined as: lymph nodes with long diameters\>15mm，extra-nodal foci\>10mm on CT scan; 5. ECOG PS (Eastern Cooperative Oncology Group Performance Status) point 0 or 1;
Exclusion criteria
1. Invasive NK cell leukemia; 2. Primary CNS lymphoma or CNS-involved lymphoma; 3. Patients with hemophagocytic syndrome; 4. Patients with lymphoma invading large pulmonary vessels; 5. Patients primarily resistant to anti-PD1,PD-L1,PD-L2 antibodies (generally considered as those received anti- PD1,PD-L1,PD-L2 antibodies as monotherapy or in combination with chemotherapy, but did not achieve PR or CR in non-maintenance treatment).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR(evaluated by the independent review committee according to Lyric 2016 criteria.) | After the last subject completed follow-up visit of up to 24 weeks | To evaluate the objective response rate (ORR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CR/PR | After the last subject completed follow-up visit of up to 24 weeks | To evaluate the complete response (CR) rate and partial response (PR) rate of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) |
| DCR | After the last subject completed follow-up visit of up to 24 weeks | To evaluate the disease control rate (DCR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) |
| TTR2016 criteria.) | After the last subject completed follow-up visit of up to 24 weeks | To evaluate the time to response (TTR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) |
| ORR | After the last subject completed follow-up visit of up to 24 weeks | To evaluate the objective response rate (ORR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) determined by the investigators according to Lugano 2014 criteria and Lyric 2016 criteria |
| PFS | After the last subject completed follow-up visit of up to 24 weeks | To evaluate the progression-free survival (PFS) and PFS rate at 12 months of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) |
| OS(evaluated by the investigators according to Lugano 2014 criteria and Lyric 2016 criteria.) | After the last subject completed follow-up visit of up to 24 weeks | To evaluate the overall survival (OS) and OS at 12 months of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) |
| adverse events | from enrollment until the last patient finishes OS follow-up, or finishes 24-month treatment and corresponding safety follow-up, whichever comes first. | To evaluate the safety profile of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) |
| DOR | After the last subject completed follow-up visit of up to 24 weeks | To evaluate the duration of response (DOR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) |
Countries
China
Outcome results
None listed