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An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy with Tenofovir in HBsAg-positive Patients with Diffuse Large B-cell Lymphoma Receiving Rituximab-CHOP Chemotherapy (SPEED study)
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage number of patients with hepatitis due to HBV reactivation | Percentage number of patients with hepatitis due to HBV reactivation during the preemptive tenofovir therapy and for 24 weeks after withdrawal from tenofovir. Definition;
| 2 years (every 3 months) |
| Percentage number of patients with hepatitis due to Safety assessment | Safety assessment; NCI CTCAE v 4.0 and tolerability evaluation - drug compliance | 2 years (every 3 months) |
| Chemotherapy disruption due to hepatitis | Chemotherapy disruption due to hepatitis: defined as either premature termination or delay of more than 8 days between chemotherapy cycles. | 2 years (every 3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Previously untreated Diffuse Large B-cell Lymphoma (DLBCL) with HBsAg (+) who are suitable for receiving R-CHOP chemotherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Do young Kim, MD | Contact | 82-2-2228-1992 | DYK1025@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Recruiting | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36728217 | Derived | Kim DY, Kim YR, Suh C, Yoon DH, Yang DH, Park Y, Eom HS, Lee JO, Kwak JY, Kang HJ, Hyun SY, Jo JC, Chang MH, Yoo KH, Lim SN, Shin HJ, Kim WS, Kim IH, Kim MK, Kim HJ, Lee WS, Mun YC, Kim JS. A Prospective Study of Preemptive Tenofovir Disoproxil Fumarate Therapy in HBsAg-Positive Patients With Diffuse Large B-Cell Lymphoma Receiving Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone. Am J Gastroenterol. 2023 Aug 1;118(8):1373-1380. doi: 10.14309/ajg.0000000000002185. Epub 2023 Jan 13. |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| 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 |
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