Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Frail Patients with Treatment-naive Non-GCB DLBCL
NCT06530511 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-02-04
Summary
This prospective, single-arm, multicenter clinical study aims to enroll 30 frail elderly patients with Non-GCB DLBCL. This study is to evaluate the preliminary efficacy and safety of the combination of Polatuzumab, Rituximab, and orelabrutinib in this population. The primary endpoint is CR rate after induction therapy.
Conditions
Interventions
- DRUG
-
Polatuzumab vedotin
Polatuzumab: 1.8 mg/kg, IV Drip infusion, D1;
- DRUG
-
Rituximab: 375 mg/m2, IV Drip infusion, D1
- DRUG
-
Orelabrutinib
Orelabrutinib: 150 mg/time, qd, po, D1-21
Sponsors & Collaborators
-
Affiliated Hospital of Nantong University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-01
- Primary Completion
- 2026-02-01
- Completion
- 2026-08-01
Countries
- China
Study Locations
More Related Trials
-
Orelabrutinib Combined With R-CDOP for DLBCL Patients With High-risk of CNS Relapse Defined by CNS-IPI
NCT06290817 ·Status: RECRUITING ·Phase: PHASE2
-
Prospective Clinical Study of ZPR Regimen in Elderly Treatment-naive Diffuse Large B-cell Lymphoma
NCT05940064 ·Status: RECRUITING ·Phase: PHASE2
-
An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL
NCT06015464 ·Status: UNKNOWN
-
Prospective Clinical Study of Orelabrutinib in Combination With Rituximab (OR) for Primary Marginal Zone Lymphoma (MZL) That Failed or Not Suitable for Local Therapy
NCT06478472 ·Status: RECRUITING ·Phase: NA
-
Prospective Clinical Study of ZPR Regimen in Relapsed/Refractory Diffuse Large B-cell Lymphoma
NCT05940051 ·Status: RECRUITING ·Phase: PHASE2
-
A Prospective Clinical Study of the Combination Therapy of Obutinib or Decitabine with Rituximab, Cyclophosphamide, and Prednisone for the Primary Treatment of Elderly Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma
NCT06683885 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Orelabrutinib in Combination With R2 Regimen for R/R CD20+ B-cell Lymphoma
NCT05014100 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
NCT05933967 ·Status: RECRUITING ·Phase: PHASE2
-
Large Fraction Radiation Therapy Combined With Lenalidomide, and Glofitamab in Refractory Relapsed DLBCL
NCT06651853 ·Status: RECRUITING ·Phase: PHASE2
-
Pola-R2 in Newly Diagnosed Non-fit Elderly DLBCL Patients
NCT06176729 ·Status: RECRUITING ·Phase: PHASE2
-
Evaluation of the Efficacy and Safety of Polatuzumab Vedotin Combined With Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as Salvage Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients Ineligible for Autologous Transplantation
NCT07001540 ·Status: RECRUITING ·Phase: PHASE2
-
Combination of Orelabrutinib and Obinutuzumab in Untreated Marginal Zone Lymphomas
NCT06513234 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Pomalidomide Combination with Rituximab and Anti-PD-1 Antibody (PPR) in Third or Later Line Therapy of DLBCL
NCT06832228 ·Status: RECRUITING ·Phase: NA
-
Evaluate the Safety and Efficacy of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NCT06521255 ·Status: RECRUITING ·Phase: PHASE3
-
An Observational Study of MabThera/Rituxan (Rituximab) Plus Chemotherapy As First-Line Treatment in Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
NCT01340443 ·Status: COMPLETED
-
R-CHOP Versus R-CDOP as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma
NCT02428751 ·Status: UNKNOWN ·Phase: PHASE3
-
A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL
NCT06516978 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study of Brentuximab Vedotin, Rituximab, and Dose Attenuated CHP in Elderly Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
NCT02734771 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study in Patients With Primary Breast Diffuse Large B-cell Lymphoma
NCT01448096 ·Status: COMPLETED ·Phase: PHASE2
-
Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL
NCT07012980 ·Status: NOT_YET_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
-
Study of Orelabrutinib in Combination With Gemox in Refractory / Relapsed Diffuse Large B-cell Lymphoma
NCT05381506 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Pirtobrutinib in Combination With Rituximab, Gemcitabine, Oxaliplatin With or Without Polatuzumab Vedotin in Covalent BTK Inhibitor-Pretreated Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NCT07122609 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pola), and Atezolizumab (Atezo) in Participants With Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab, Atezo, and Pola in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
NCT02729896 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
NCT03332017 ·Status: COMPLETED ·Phase: PHASE2