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

A Single-arm Clinical Study of Azacitidine in Combination With R-CHOP (ARCHOP) for the Treatment of TP53-mutated Previously Untreated Diffuse Large B-cell Lymphoma

This study is testing if adding Azacitidine to the standard R-CHOP treatment can help people with untreated Diffuse Large B-cell Lymphoma who have TP53 mutations feel better and live longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Xiamen University (other)
• Locations: 1 site (Xiamen, Fujian)
• Trial ID: NCT06158399 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with newly diagnosed TP53-mutated DLBCL and an ECOG performance status of 0-2.

Not a fit: Patients with primary or secondary central DLBCL, active HIV or HCV infections, or significant cardiovascular disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with a challenging mutation in DLBCL.

How similar studies have performed: While there is ongoing research in this area, the combination of Azacitidine with R-CHOP specifically for TP53-mutated DLBCL is a novel approach.

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

Where this trial is running

Xiamen, Fujian

• Bing Xu — Xiamen, Fujian, China (RECRUITING)

Study contacts

• Principal investigator: Bing Xu — The First Aiffiliated hosptical of xiamen University
• Study coordinator: Bing Xu

Conditions: DLBCL - Diffuse Large B Cell Lymphoma, TP53