AZA Combined With RCHOP in P53-mutated DLBCL.

Launched by THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIVERSITY · Nov 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with a specific type of cancer called Diffuse Large B-cell Lymphoma (DLBCL), which is often associated with a mutation in a gene known as TP53. Researchers want to see if combining a medication called Azacitidine with the standard treatment known as R-CHOP (which includes several chemotherapy drugs) can be effective in treating patients who have not yet received treatment for their cancer. The trial is currently looking for participants aged 18 to 70 who have this TP53-mutated DLBCL and meet certain health criteria.

If you or a loved one is considering joining this trial, it's important to know that participants will be carefully monitored for both the effectiveness of the treatment and any potential side effects. To be eligible, individuals must be in relatively good health, without certain other medical conditions, and should have a life expectancy of at least six months. The trial aims to provide insight into how well this new combination therapy works and what it means for future treatments of this type of lymphoma.

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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 other malignant tumors; 7) Known hypersensitivity or allergic reaction to antibodies or proteins of the murine family