Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06158399

AZA Combined With RCHOP in P53-mutated DLBCL.

Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-02-19

52

Participants Needed

1

Research Sites

131 weeks

Total Duration

On this page

Sponsors

T

The First Affiliated Hospital of Xiamen University

Lead Sponsor

J

Jiangsu Provincial People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

AZA Combined With RCHOP in P53-mutated DLBCL.

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 70 years
  • New diagnosis of TP53-mutated Diffuse Large B-cell Lymphoma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Left ventricular ejection fraction (LVEF) greater than 45%
  • If hepatitis B virus (HBV) positive, HBV-DNA test must be negative before enrollment
  • Liver function with serum bilirubin ≤ 2.0 times upper limit of normal (ULN), serum ALT and AST ≤ 2.5 times ULN
  • Renal function with serum creatinine ≤ 2.0 times ULN unless due to lymphoma
  • Life expectancy of at least 6 months
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Primary or secondary central nervous system involvement by DLBCL
  • HIV-positive status or active hepatitis C virus infection
  • Clinically significant secondary cardiovascular disease
  • Severe chronic obstructive pulmonary disease with combined hypoxemia
  • Active bacterial, fungal, or viral infections not controlled by systemic therapy
  • Other malignant tumors diagnosed within the last 3 years except cured basal cell carcinoma of the skin, cervical cancer in situ, early prostate cancer not requiring systemic therapy, or early breast cancer treated only with surgery
  • Known hypersensitivity or allergic reaction to antibodies or proteins of murine origin

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Bing Xu

Xiamen, Fujian, China, 361000

Actively Recruiting

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Research Team

B

Bing Xu

CONTACT

Z

Zhifeng Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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