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The goal of this phase 2 trial is to test the safety and efficacy of G-Pola-GemOx as induction therapy in patients with Refractory/Relapsed Aggressive B-Cell Lymphoma.
The investigators will evaluate safety and efficacy of G-Pola-GemOx as induction therapy in Refractory/Relapsed Aggressive 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 |
|---|---|---|---|
| Induction Therapy | Experimental | Patients were treated by G-Pola-GemOx as Induction Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glofitamab, Polatuzumab Vedotin, Gemcitabine, and Oxaliplatin as Induction Therapy | Drug | Patients were treated by Glofitama(Cycle 1: D8, 2.5mg, D15, 10mg; followed by the target dose of 30mg on D1 of Cycle 2-12), Polatuzumab Vedotin(1.8mg/kg iv qd d1), Gemcitabine (1000 mg/m2 iv qd d2), Oxaliplatin (100 mg/m2 iv qd d2) as induction therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR was defined as the proportion of patients who achieved CR or PR as their best response | 1 year |
| 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 |
| Progression Free Survival (PFS) | For patients in morphologic remission, documented relapse was considered progression. Relapse following complete remission(CR) is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the BM, not attributable to another cause (eg, BM regeneration after consolidation therapy) or extramedullary relapse. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liren Qian | Contact | +861066947194 | qlr2007@126.com | |
| Liren Qian | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Liren Qian | Navy General Hospital, Beijing | Principal Investigator |
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| ID | Term |
|---|---|
| C000720108 | glofitamab |
| C000600736 | polatuzumab vedotin |
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
|
| 2 years] |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |