NCT06158399

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
1mo left

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Nov 2023May 2026

First Submitted

Initial submission to the registry

November 22, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 22, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

2.5 years

First QC Date

November 22, 2023

Last Update Submit

February 18, 2025

Conditions

DLBCL - Diffuse Large B Cell LymphomaTP53

Outcome Measures

Primary Outcomes (1)

  • Complete remission rate (CR)

    CR is evaluated according to the Lugano criteria for lymphoma response.

    Up to 36 months

Secondary Outcomes (3)

  • Partial remission rate (PR)

    Up to 36 months

  • Overall response rate (ORR)

    Up to 36 months

  • Progression Free Survival (PFS)

    Up to 36 months

Study Arms (1)

ARCHOP

EXPERIMENTAL

Azacitidine in combination with R-CHOP

Drug: Azacitidine in combination with R-CHOP

Interventions

Azacitidine in combination with R-CHOPDRUG

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

ARCHOP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • Primary and secondary central DLBCL;
  • HIV-positive patients and or HCV active infection; (3) Clinically significant secondary cardiovascular disease;
  • \) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bing Xu

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Dendritic Cell Sarcoma, Interdigitating

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Histiocytic Disorders, MalignantNeoplasms by Histologic TypeNeoplasmsHistiocytosisLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Bing Xu

    The First Aiffiliated hosptical of xiamen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Xu

CONTACT

+8618750918842xubingzhangjian@126.com

Zhifeng Li

CONTACT

+8613606901162lzf_xm@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2023

First Posted

December 6, 2023

Study Start

November 22, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)