AZA Combined With RCHOP in P53-mutated DLBCL.

February 18, 2025 updated by: Bing, Xu, The First Affiliated Hospital of Xiamen University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARCHOP
Azacitidine in combination with R-CHOP
Drug: Azacitidine in combination with R-CHOP

Specified dose on specified days:

Azacitidine (A) 100mg subcutaneous d-1 to d-5 Rituximab (R) 375mg/m2 IV d0 Cyclophosphamide (C) 750mg/m2 IV d1 epirubicin (H) 75mg/m2 IV d1 or liposomal adriamycin (D) 25-30mg/m2 IV d1 Vincristine (O) 1.4mg/m2 (max 2mg) IV d1 Prednisone (P) 100mg orally d1-5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete remission rate (CR)
Time Frame: Up to 36 months
CR is evaluated according to the Lugano criteria for lymphoma response.
Up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partial remission rate (PR)
Time Frame: Up to 36 months
PR is evaluated according to the Lugano criteria for lymphoma response.
Up to 36 months
Overall response rate (ORR)
Time Frame: Up to 36 months
Percentage of participants with best overall response of partial response (PR) and complete response (CR), using the Lugano criteria.
Up to 36 months
Progression Free Survival (PFS)
Time Frame: 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.
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xiamen University

Collaborators

Shanxi Province Cancer Hospital
Sun Yat-sen University
Jiangsu Provincial People's Hospital
Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Bing Xu, The First Aiffiliated hosptical of xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XMDYYYXYK-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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