RecruitingPhase 2NCT06158399

AZA Combined With RCHOP in P53-mutated DLBCL.

A Single-arm Clinical Study of Azacitidine in Combination With R-CHOP (ARCHOP) for the Treatment of TP53-mutated Previously Untreated Diffuse Large B-cell Lymphoma


Sponsor

The First Affiliated Hospital of Xiamen University

Enrollment

52 participants

Start Date

Nov 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy and adverse effects of Azacitidine in combination with R-CHOP (ARCHOP) for the treatment of TP53-mutated previously untreated Diffuse large B-cell lymphoma


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding azacitidine (AZA), a drug that affects how genes are switched on and off, to the standard R-CHOP chemotherapy regimen improves outcomes in patients with a type of aggressive blood cancer called diffuse large B-cell lymphoma (DLBCL) that has a TP53 gene mutation. **You may be eligible if...** - You are between 18 and 70 years old - You have been newly diagnosed with DLBCL that has a TP53 gene mutation - You have not previously received treatment for this lymphoma - Your heart function is adequate (LVEF above 45%) - Your liver, kidney, and blood counts meet the required levels **You may NOT be eligible if...** - You have already received treatment for DLBCL - Your DLBCL does not have a TP53 mutation - You are outside the age range of 18 to 70 - You have significant liver, heart, or kidney problems 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

DRUGAzacitidine in combination with R-CHOP

Specified dose on specified days: Azacitidine (A) 100mg subcutaneous d-1 to d-5 Rituximab (R) 375mg/m2 IV d0 Cyclophosphamide (C) 750mg/m2 IV d1 epirubicin (H) 75mg/m2 IV d1 or liposomal adriamycin (D) 25-30mg/m2 IV d1 Vincristine (O) 1.4mg/m2 (max 2mg) IV d1 Prednisone (P) 100mg orally d1-5


Locations(1)

Bing Xu

Xiamen, Fujian, China

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NCT06158399


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