AZA Combined With RCHOP in P53-mutated DLBCL.

• Status: Recruiting
• Trial end date: 2025-05-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Xiamen University
• Collaborators: Chinese Academy of Medical Sciences; Jiangsu Provincial People's Hospital; Shanxi Province Cancer Hospital; Sun Yat-sen University
• Treatments: Azacitidine

Criteria

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