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This phase II trial studies how well giving rituximab,chidamide, and zanubrutinib with Sequential chemotherapy works in treating patients with double express diffuse large B-cell lymphoma. The prognosis of patients with DEL-DLBCL is usually worse than that of ordinary DLBCL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (RCZ WITH CHOP) | Experimental | Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab, Chidamide, Zanubrutinib-induced and CHOP Therapy | Drug | All subjects received two courses of the following treatment: Rituximab ,375mg/m², D1; Chidamiade ,20mg ,biw, d1-14; Zanubrutinib ,160mg, bid, d1-21; three weeks for a period of treatment, all subjects complete tumor assessment after two courses of treatment, patients which achieve complete remission continue for up to 8 sessions, patients achieve partial response and stable disease combined use of the following CHOP threapy to 6 courses, Patients with progressive disease dropped out of this research. CHOP Therapy: Cyclophosphamide, 750mg/m² ,D1; Vincristine, 1.4mg/m² ,D1 (maximum:2mg); Doxorubicin or pirarubicin, 50mg/m², D1; Prednisone ,30mg ,tid, D1-5. |
| Measure | Description | Time Frame |
|---|---|---|
| EOT-CRR | End of Treatment Complete Response Rate | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| EOT-ORR | End of Treatment Overall Response Rate | 12 months |
| EOT-CRR2 | End of Initial two courses of Treatment Complete Response Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li, Zhiming, M.D. | Contact | 02087343292 | Lizhm@sysucc.org.cn | |
| Sun Peng, M.D. | Contact | 02087343292 | sunp@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Oncology,Sun Yat-Sen University Cancer Center | Not yet recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
|
| 2 months |
| 2year-PFS | 2-year Progression Free Survival Rate | 24 months |
| 2year-OS | 2-year Overall Survival Rate | 24 months |
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | China |
|
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |