Efficacy and Safety of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL
NCT06803693 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152
Last updated 2025-12-08
Summary
The purpose of this study is to compare the efficacy and safety of genotype-guided targeted agents in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola RCHP-X) versus Pola RCHP in Chinese patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
Conditions
- Diffuse Large B-Cell Lymphoma
Interventions
- DRUG
-
Polatuzumab vedotin
Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
- DRUG
-
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
- DRUG
-
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
- DRUG
-
Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
- DRUG
-
Prednisone PO will be administered as per the schedule specified in the respective arm.
- DRUG
-
Zanubrutinib PO will be administered as per the schedule specified in the respective arm.
- DRUG
-
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
- DRUG
-
Decitabine
Decitabine IV infusion will be administered as per the schedule specified in the respective arm.
Sponsors & Collaborators
-
Ruijin Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-01
- Primary Completion
- 2028-04-30
- Completion
- 2028-12-31
Countries
- China
Study Locations
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