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Study Purpose: To evaluate the efficacy and safety of sintilimab in combination with AVD chemotherapy for the treatment of pediatric and adolescent patients with low-to-intermediate risk classical Hodgkin lymphoma (cHL).
Study Design: This is a prospective, single-arm, multicenter, phase II clinical trial.
Study Population: Pediatric and adolescent patients aged 1 to 18 years, diagnosed with classical Hodgkin lymphoma, and classified as low-to-intermediate risk according to the Ann Arbor staging system.
Treatment Plan: Sintilimab in combination with AVD chemotherapy, administered every two weeks for a planned 4-6 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab+AVD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab in combination with AVD chemotherapy | Drug | Sintilimab in combination with AVD chemotherapy treating classical Hodgkin lymphoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| 4-year event-free survival | The 4-year event-free survival (EFS) rate of pediatric and adolescent patients with low-to-intermediate risk classical Hodgkin lymphoma (cHL) treated with sintilimab in combination with the AVD regimen. EFS is defined as the time from study entry to the occurrence of disease progression, relapse, second primary malignancy, or death. | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yizhuo Zhang | Contact | +86 020-87342460 | zhangyzh@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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