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The goal of this phase 2 trial is to test the safety and efficacy of Pola-ZR2P as induction therapy in patients with DLBCL.
The investigators will evaluate safety and efficacy of Pola-ZR2P as induction therapy in Previously Untreated Diffuse Large B-Cell Lymphoma. ORR(Overall response rate, progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pola-ZR2P | Experimental | Patients were treated by Pola-ZR2P as Induction Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polatuzumab Vedotin, Zanubrutinib, Rituximab, Lenalidomide and Prednisone as Induction Therapy | Drug | Patients were treated by Polatuzumab Vedotin(1.8mg/kg iv qd d1), Zanubrutinib(160mg po bid d1-21), Rituximab(375mg/m2 iv qd d1), Lenalidomide(25mg po qd d1-14) and Prednisone(60mg/m2 po qd d1-5) as induction therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Progression was defined according to the Lugano Response Criteria | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as time from diagnosis to death from any cause or the last follow-up | through study completion, an average of 2 years |
| Overall Response Rate (ORR) | ORR was defined as the proportion of patients who achieved CR or PR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liren Qian, PhD | Contact | +861066947194 | qlr2007@126.com | |
| Liren Qian, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Liren Qian, PhD | Navy General Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Navy General Hospital | Recruiting | Beijing | Beijing Municipality | 100048 | 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 |
|---|---|
| C000600736 | polatuzumab vedotin |
| C000629551 | zanubrutinib |
| D000069283 | Rituximab |
| D000077269 | Lenalidomide |
| D011241 | Prednisone |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
|
| 1 year |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |