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To evaluate the efficacy and safety of chidamide monotherapy as maintenance treatment in patients with diffuse large B-cell lymphoma (DLBCL) and HBV infection following initial response to R-CHOP therapy, and to provide evidence for the clinical application of chidamide.
Primary endpoint is 2-year progression-free survival (PFS). Secondary endpoints include overall survival (OS), safety parameters, and exploratory biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chidamide group | Experimental | Chidamide is administered at a dose of 20 mg (4 tablets) twice weekly, i.e., on Days 1, 4, 8, 11, 15, 18, 22, and 25, with every 4 weeks constituting one treatment cycle. Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily) |
|
| Control group | Active Comparator | Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide | Drug | Chidamide is administered at a dose of 20 mg (4 tablets) twice weekly, i.e., on Days 1, 4, 8, 11, 15, 18, 22, and 25, with every 4 weeks constituting one treatment cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | The time from study enrollment to the first documented disease progression or death from any cause, whichever occurs first. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | To assess the Overall Response Rate (ORR) referred to Lugano 2014. | 24 months |
| Overall survival(OS) | Overall survival(OS) is defined as the time from the date of enrollment to the date of death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ou Bai, PHD | Contact | 15804302602 | oubai16@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ou Bai, PHD | The First Bethune Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Bethune Hospital of Jilin University | Recruiting | Changchun | Jilin | China |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| C000613826 | HBI-8000 |
| C413685 | entecavir |
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| Entecavir Tablets | Drug | Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily) |
|
|
| 24 months |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |