Overview
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
Description
This is a Phase 2, open-label clinical trial study that aims to evaluate the efficacy (eg. Complete response, Overall Survival, Progression Free Survival) 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
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