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This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD8586 versus investigator's choice in participants with chronic lymphocytic leukemia/small lymphocytic lymphoma who have progressed following prior therapy.
Primary objective of this study is to assess the efficacy using progression free survival assessed by independent review committee as primary endpoint. Approximately 250 participants are estimated to be randomized into the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily dose of DZD8586 (Birelentinib) | Experimental |
| |
| Investigator's choice | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DZD8586 | Drug | Orally, 50 mg, once daily until treatment discontinuation criterion is met. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) assessed by Independent Review Committee (IRC) | Approximately 36 Months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS assessed by investigator | Approximately 36 Months | |
| Objective response rate (ORR) by IRC and investigator | Approximately 36 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cong Wei | Contact | 0086-21-61097873 | Cong.Wei@dizalpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Dizal Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| C552946 | idelalisib |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Bendamustine | Drug | Administered intravenously |
|
| Idelalisib | Drug | Administered orally |
|
| Rituximab | Drug | Administered intravenously |
|
| National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College | Recruiting | Tianjin | Tianjin Municipality | China |
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009588 |
| Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |