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It is a phase II, multicenter, open-label study is to evaluate the safety, efficacy and pharmacokinetics of a novel BTK inhibitor, ICP-022, in approximately 85 subjects with R/R DLBCL. There will be no control group in this study. Each subject will receive treatment orally every day in 28-day cycles. Each cycle starts immediately after the previously completed cycle without a break between cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-022 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-022 | Drug | ICP-022 is a white, round, uncoated tablet, 50 mg. It is administered orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate(ORR) | The efficacy measured by overall response rate (ORR) according to the 2014 International Working Group NHL | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events and serious adverse events | The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 5.0 grading criteria | Up to 3 years |
| Progression free survival(PFS) |
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Key Inclusion criteria:
Key Exclusion criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China | ||
| Affiliated Tumor Hospital of Harbin Medical University |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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The efficacy measured by progression free survival(PFS)
| Up to 3 years |
| Duration of response(DOR) | Up to 3 years |
| Haerbin |
| Heilongjiang |
| China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | China |
| The Fourth Hospital of Hebei Medical University | Hebei | Shijiazhuang | China |
| Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) | Tianjin | Tianjin Municipality | China |
| The First Affiliated Hospital of Zhejiang University Medical College | Hangzhou | Zhejiang | 310000 | China |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |