AZA Combined With RCHOP in P53-mutated DLBCL.
This study tests a new combination treatment called ARCHOP, which adds a drug called Azacitidine to the standard chemotherapy regimen R-CHOP, for patients with a specific type of lymphoma (DLBCL) that has a TP53 gene mutation. The goal is to see if this combination is more effective than standard treatment and to understand what side effects patients might experience.
Key Objective: This trial is testing whether adding Azacitidine to standard R-CHOP chemotherapy improves treatment outcomes for patients with TP53-mutated DLBCL, which typically has a poorer prognosis.
Who to Consider: Patients with newly diagnosed diffuse large B-cell lymphoma that has a TP53 gene mutation and who have not received prior treatment should consider enrolling in this trial.
Trial Parameters
Brief 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 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 oth