The Efficacy and Safety of Pola-ZR-Glo in Older Treatment-naive Patients With LBCL
NCT07514169 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-08
Summary
This is a prospective, single-center, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) regimen in older treatment-naive patients with large B-cell lymphoma.
Conditions
- Large B-Cell Lymphoma (LBCL)
Interventions
- DRUG
-
Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) regimen
Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 12 cycles. Dosage: Polatuzumab vedotin (1.8 mg/kg) will be administered intravenously on Day 2 of Cycle 1 and on Day 1 of Cycles 2-6 (each Q3W). Zanubrutinib (160mg bid p.o.) will be administered from D1 to D21 through Cycles 1-6 Q3W. Lenalidomide (25mg qd p.o.) will be administered from D2 to D11 through Cycles 1-6 Q3W. Glofitamab will be administered i.v. on a step-up dosing schedule starting on Day 8 of Cycle 1 (2.5 mg), Day 15 of Cycle 1 (10 mg), followed by 30 mg on Day 1 of Cycles 2-12, with each cycle being 21 days. A single dose of obinutuzumab 1000 mg will be administered intravenously on Day 1 of Cycle 1.
Sponsors & Collaborators
-
Ruijin Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2028-12-31
- Completion
- 2029-12-31
Countries
- China
Study Locations
More Related Trials
-
Pola-R2 in Newly Diagnosed Non-fit Elderly DLBCL Patients
NCT06176729 ·Status: RECRUITING ·Phase: PHASE2
-
Application of Zanubrutinib-based Combination Regimens in the Treatment of Newly-diagnosed Diffuse Large B-cell Lymphoma
NCT07371923 ·Status: RECRUITING ·Phase: PHASE2
-
An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma
NCT06047080 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Efficacy and Safety of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL
NCT06803693 ·Status: RECRUITING ·Phase: PHASE2
-
The Efficacy and Safety of ZR2 Versus R-miniCHOP in the Treatment of Unfit or Frail de Novo Diffuse Large B-cell Lymphoma Patients Aged Older Than or Equal to 70 Years
NCT05179733 ·Status: RECRUITING ·Phase: PHASE3
-
Prospective Clinical Study of ZPR Regimen in Relapsed/Refractory Diffuse Large B-cell Lymphoma
NCT05940051 ·Status: RECRUITING ·Phase: PHASE2
-
Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL
NCT07072208 ·Status: RECRUITING ·Phase: NA
-
The Efficacy and Safety of ZR2 Versus R-CHOP-like Regimen for Elderly Patients With Newly Diagnosed Diffuse Large B Cell Lymphoma.
NCT05428670 ·Status: UNKNOWN ·Phase: PHASE2
-
Glofitamab Plus Polatuzumab Vedotin and Zuberitamab in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma
NCT07231250 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Zanubrutinib, Lenalidomide and Rituximab (ZR2) in Elderly Treatment-naive Patients With Diffuse Large B-cell Lymphoma (DLBCL)
NCT04460248 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Zanubrutinib, Obinutuzumab Combined With Lenalidomide (ZGR) for the Treatment of Untreated Follicular Lymphoma
NCT07299149 ·Status: RECRUITING ·Phase: PHASE2
-
Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP
NCT05798156 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study to Evaluate the Effectiveness and Safety of Polatuzumab in Real World Clinical Practice Among Adult Chinese Participants With Diffuse Large B-Cell Lymphoma
NCT05954910 ·Status: ACTIVE_NOT_RECRUITING
-
A Phase II Study of Zanubrutinib, Lenalidomide Plus R-CHOP as the First-line Treatment for Diffused Large B-cell Lymphoma
NCT05200312 ·Status: UNKNOWN ·Phase: PHASE2
-
Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients with Follicular Lymphoma (FL)
NCT06549335 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
The Efficacy and Safety of Glofitamab in Combination With PD-1 Antibody and Lenalidomide in Patients With Relapsed/Refractory Large B-cell Lymphoma (LBCL) With TP53 Aberrations: A Prospective, Multicenter, Phase II Clinical Study
NCT07240194 ·Status: RECRUITING ·Phase: PHASE2
-
Zanubrutinib-based Maintenance Therapy of Newly Diagnosed DLBCL With Initial Remission
NCT06669143 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Efficacy of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL
NCT06441097 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
The Effectiveness and Safety of Glofitamab in Real-World Clinical Practice Among Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter Study
NCT06656234 ·Status: NOT_YET_RECRUITING
-
A Study of Zanubrutinib in Combination With Polatuzumab Vedotin, Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma
NCT06554600 ·Status: RECRUITING ·Phase: PHASE2
-
Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in the Treatment of Newly Diagnosed Splenic B-cell Lymphoma With Prominent Nucleoli (SBLPN): A Prospective, Open-label, Single-arm Clinical Trial
NCT07165769 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Polatuzumab Vedotin, Rituximab and Dose Attenuated CHP in Older Patients With DLBCL
NCT04594798 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL
NCT03467373 ·Status: COMPLETED ·Phase: PHASE1
-
The Study of Pegylated Liposomal Doxorubicin Contrast Epirubicin for the Treatment of Diffuse Large B-cell Lymphoma
NCT03022123 ·Status: UNKNOWN ·Phase: NA
-
Novel Targeted Drugs Combined With R-ICE Regimen in Relapsed and Refractory Diffuse Large B-cell Lymphoma
NCT05348213 ·Status: RECRUITING ·Phase: PHASE2