RecruitingPhase 3NCT05351346

Genotype-guided Treatment in DLBCL

A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma

Sponsor

Ruijin Hospital

Enrollment

1,100 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma

Summary

A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-X) versus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with diffuse large B-cell lymphoma

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether personalizing chemotherapy treatment for diffuse large B-cell lymphoma (DLBCL) — an aggressive type of blood cancer — based on the specific genetic makeup (genotype) of a patient's tumor leads to better outcomes than standard treatment. **You may be eligible if...** - You have been newly diagnosed with DLBCL (not involving the brain) - Your tumor tissue is available for genetic testing - Your disease is intermediate to high risk (IPI score of 2–5, or 1 with bulky disease) - Your general health and organ function meet study requirements **You may NOT be eligible if...** - You have received prior chemotherapy or a stem cell transplant - You have another active cancer - You have lymphoma in the brain or central nervous system - You have HIV, hepatitis B, or hepatitis C - Your heart function (ejection fraction) is below 50% - You have uncontrolled cardiovascular disease, blood clotting disorders, or serious infections 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

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.

DRUGVincristine

Vincristine 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.

DRUGOrelabrutinib

Orelabrutinib 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 Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT05351346

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