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| Name | Class |
|---|---|
| Tianjin First Central Hospital | OTHER |
| The First Affiliated Hospital of Air Force Medicial University | OTHER |
| The First Hospital of Jilin University | OTHER |
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Indolent T/NK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T/NK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T/NK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed/refractory indolent T/NK-cell lymphomas. Patients will be treated with Golidocitnib, with an expected overall response rate of 60% for JAK1 inhibitor Golidocitnib treatment.
Plan to enroll 48 patients with relapsed/refractory indolent T/NK-cell lymphomas; they will receive JAK1 inhibitor treatment (Golidocitnib150mg QD orally, with a 28-day cycle). Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JAK1 inhibitor | Experimental | Golidocitnib 150mg QD orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JAK1 Inhibitor | Drug | Golidocitnib 150mg QD orally, with a 28-day cycle. Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | complete remission rate + partial remission rate | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of JAK1 inhibitor | Incidence of adverse events, serious adverse events and significant adverse event | up to 5 years |
| Complete remession rate | Hematological PR was defined as an improvement in blood counts ANC > 0.5 × 109/L; HGB increased by >1 g/dL; PLT > 50 × 109/L |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuhua Yi, Doctor | Contact | 86-22-23909106 | yishuhua@ihcams.ac.cn | |
| Lugui Qiu, Doctor | Contact | 86-22-23909172 | qiulg@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, China | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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| The First Affiliated Hospital of Nanchang University |
| OTHER |
| Henan Cancer Hospital | OTHER_GOV |
| Second Xiangya Hospital of Central South University | OTHER |
| Tongji Hospital | OTHER |
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|
| up to 5 years |
| Duration of remission | the time from response to progression/death (P/D) | up to 5 years |
| Time to response | from the start of treatment to the first observed partial remission | up to 5 years |
| Progression-free survival | the time from treatment initiation until disease progression or death | up to 5 years |
| Overall survival | The time from the start of treatment to the patient's death from any cause | up to 5 years |
| Disease control rate | the proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage of patients who achieve complete response (CR), partial response (PR), and stable disease (SD). | up to 5 years |
| Institute of Hematology & Blood Diseases Hospital | Not yet recruiting | Tianjin | 300020 | China |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D054066 | Leukemia, Large Granular Lymphocytic |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015458 | Leukemia, T-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
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