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This study will treat patients with B-NHL who have relapsed, progressed, or were intolerant to systemic therapy progressed following prior therapy. This study will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and assess its anti-cancer activity as monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DZD8586 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DZD8586 | Drug | DZD8586 treatment starting from 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD8586. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Incidence of adverse events | 30 days after the last dose, assessed up to 2 years | |
| Part B: Objective Response Rate assessed by investigators | assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Objective Response Rate assessed by investigators | assessed up to 2 years | |
| Part A: Plasma and CSF concentration of DZD8586 | through discontinuation of treatment up to 10 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tianwei Zhang | Dizal Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | New York | New York | 10065 | United States | ||
| Research site |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| Part B: Duration of Response assessed by investigators |
| from date of first documented response until the date of documented progression, assessed up to 2 years |
| Part B: Incidence of adverse events | 30 days after the last dose, assessed up to 2 years |
| Part B: Plasma and CSF concentration of DZD8586 | through discontinuation of treatment, assessed up to 2 years |
| Albury |
| New South Wales |
| Australia |
| Research site | Ballarat | Victoria | Australia |
| Research site | Melbourne | Victoria | Australia |
| Research site | Perth | Western Australia | Australia |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |