Combining Azacitidine with R-CHOP for treating TP53-mutated DLBCL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 open-label clinical trial evaluates the effectiveness and safety of Azacitidine in combination with R-CHOP for patients with previously untreated Diffuse Large B-cell Lymphoma (DLBCL) that have TP53 mutations. The study aims to measure outcomes such as complete response rates, overall survival, and progression-free survival while monitoring adverse effects. Eligible participants will be closely monitored throughout the treatment process to assess the combined therapy's impact on their condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

(1)18-70 years old; 2) New-onset TP53 mutant DLBCL; 3) ECOG 0-2; 4) LVEF \>45%; 5) HBV-positive serology (occult carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +/-) only if HBV-DNA test is negative before enrollment; (6) Liver function: serum bilirubin ≤ 2.0 × ULN, serum ALT and AST ≤ 2.5 × ULN. Renal function: serum Cr ≤ 2.0 × ULN; (unless due to lymphoma); 7) Life expectancy ≥ 6 months; 8) Informed consent.

Exclusion Criteria:

1. Primary and secondary central DLBCL;
2. HIV-positive patients and or HCV active infection; (3) Clinically significant secondary cardiovascular disease;

4\) Combined hypoxemia severe chronic obstructive pulmonary disease; 5) Active bacterial, fungal, and, or viral infections not controlled by systemic therapy; 6) Apart from cured basal cell carcinoma of the skin or cervical cancer in situ or early prostate cancer not requiring systemic therapy or early breast cancer requiring only surgery alone. Within the last 3 years or concurrently with other malignant tumors; 7) Known hypersensitivity or allergic reaction to antibodies or proteins of the murine family

Where it's running

• Bing Xu
  Xiamen, Fujian, China Recruiting

Study contacts

• Principal investigator: Bing Xu — The First Aiffiliated hosptical of xiamen University
• Study coordinator: Bing Xu
• Email: xubingzhangjian@126.com
• Phone: +8618750918842

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.