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This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the efficacy, safety/ tolerability and pharmacokinetic of GFH009 monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GFH009 | Experimental | all patients will be administrated with GFH009 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GFH009 | Drug | patients are planned to be administrated with GFH009 every week in a 21 days cycle, intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib: adverse events | Incidence of intolerable toxic events, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | From Screening (Day -28 to Day-1) until disease progression or survival until death (approximately 6 months) |
| Phase II: Objective Response Rate | ORR(Objective Response Rate) | From Screening (Day -28 to Day-1) until disease progression or survival until death (approximately 6 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Li | Contact | +86 21 6882 1388 | jli@genfleet.com | |
| Yuting Peng | Contact | +8613730813620 | ytpeng@genfleet.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guanzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016399 | Lymphoma, T-Cell |
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| 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 |