RecruitingPhase 2NCT06803693

Efficacy and Safety of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL

A Study to Evaluate the Efficacy and Safety of Genotype-guided Targeted Agents in Combination With POLA-RCHP VERSUS POLA-RCHP in Patients With Previously Untreated Diffuse Large B-cell Lymphoma


Sponsor

Ruijin Hospital

Enrollment

152 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a second drug (xenobiotic agent) to a standard polatuzumab-based immunotherapy regimen improves outcomes for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) — a fast-growing type of blood cancer — whose initial treatment response is insufficient after the first cycle. **You may be eligible if...** - You are between 18 and 75 years old - You have newly diagnosed, untreated CD20-positive DLBCL - Your cancer burden (IPI score) is moderate to high (2–5) - After your first cycle of treatment, a blood test (ctDNA) shows your cancer has not dropped enough - Your heart function is adequate (ejection fraction at least 50%) - Your general health is good (ECOG 0–2) **You may NOT be eligible if...** - You have already received treatment for DLBCL - You have serious organ dysfunction - You are pregnant or breastfeeding - You have uncontrolled infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPolatuzumab vedotin

Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.

DRUGRituximab

Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

DRUGCyclophosphamide

Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

DRUGDoxorubicin

Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

DRUGPrednisone

Prednisone PO will be administered as per the schedule specified in the respective arm.

DRUGZanubrutinib

Zanubrutinib PO will be administered as per the schedule specified in the respective arm.

DRUGLenalidomide

Lenalidomide PO will be administered as per the schedule specified in the respective arm.

DRUGDecitabine

Decitabine IV infusion will be administered as per the schedule specified in the respective arm.


Locations(1)

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT06803693


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