AZA Combined With RCHOP in P53-mutated DLBCL.

Phase 2

Recruiting

• Conditions: TP53; DLBCL - Diffuse Large B Cell Lymphoma
• Interventions: Drug: Azacitidine in combination with R-CHOP

• Registration Number: NCT06158399
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

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

Detailed 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

Study Timeline

• Study Start: 2023-11-22
• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-12-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARCHOP	Azacitidine in combination with R-CHOP	Azacitidine in combination with R-CHOP

Primary Outcome Measures

Name	Time	Method
Complete remission rate (CR)	Up to 36 months	CR is evaluated according to the Lugano criteria for lymphoma response.

Secondary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	Up to 36 months	Percentage of participants with best overall response of partial response (PR) and complete response (CR), using the Lugano criteria.
Progression Free Survival (PFS)	Up to 36 months	The Kaplan-Meier method will be used to estimate the rate of PFS. PFS was defined as the time from the date of treatment initiation until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Partial remission rate (PR)	Up to 36 months	PR is evaluated according to the Lugano criteria for lymphoma response.

Trial Locations

Locations (1)

Bing Xu; 🇨🇳 Xiamen, Fujian, China