Extranodal NK/T Cell Lymphoma, Nasal Type Clinical Trial
Official title:
Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type), a Multicenter, Open-label Phase Ib/II Trial
Verified date | March 2023 |
Source | Innovent Biologics (Suzhou) Co. Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 9 |
Est. completion date | February 28, 2023 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University Cancer Center | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Innovent Biologics (Suzhou) Co. Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ORR(evaluated by the independent review committee according to Lyric 2016 criteria.) | To evaluate the objective response rate (ORR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type). | After the last subject completed follow-up visit of up to 24 weeks | |
Secondary | ORR | 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 | After the last subject completed follow-up visit of up to 24 weeks | |
Secondary | CR/PR | 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) | After the last subject completed follow-up visit of up to 24 weeks | |
Secondary | DCR | To evaluate the disease control rate (DCR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) | After the last subject completed follow-up visit of up to 24 weeks | |
Secondary | TTR2016 criteria.) | To evaluate the time to response (TTR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) | After the last subject completed follow-up visit of up to 24 weeks | |
Secondary | DOR | To evaluate the duration of response (DOR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) | After the last subject completed follow-up visit of up to 24 weeks | |
Secondary | PFS | 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) | After the last subject completed follow-up visit of up to 24 weeks | |
Secondary | OS(evaluated by the investigators according to Lugano 2014 criteria and Lyric 2016 criteria.) | To evaluate the overall survival (OS) and OS at 12 months of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) | After the last subject completed follow-up visit of up to 24 weeks | |
Secondary | adverse events | To evaluate the safety profile of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type) | from enrollment until the last patient finishes OS follow-up, or finishes 24-month treatment and corresponding safety follow-up, whichever comes first. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05475925 -
A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
|
Phase 1/Phase 2 |