NCT07348575

Brief Summary

This trial was a prospective, multicenter, randomized, controlled Phase III clinical design to compare the efficacy and safety of decitabine combined with R-CHOP (R-CHOP-D) versus R-CHOP in the treatment of primary EBV+ diffuse large B-cell lymphoma (DLBCL). Sixty patients were randomized 1:1 into R-CHOP-D (trial group) or R-CHOP (control group). The trial consisted of a screening period (days -28 to -1), a treatment period, and a follow-up period (2 years after the end of the last trial).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
26mo left

Started Jul 2024

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress46%
Jul 2024Jul 2028

Study Start

First participant enrolled

July 1, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

January 16, 2026

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

January 9, 2026

Last Update Submit

January 9, 2026

Conditions

Lymphoma, Large-Cell, Diffuse

Outcome Measures

Primary Outcomes (1)

  • 2-year progression-free survival

    2 year

Study Arms (2)

Decitabine in combination with R-CHOP

EXPERIMENTAL

Decitabine in combination with R-CHOP

Drug: Decitabine in combination with R-CHOP

R-CHOP

ACTIVE COMPARATOR

R-CHOP

Drug: R-CHOP

Interventions

R-CHOPDRUG

Decitabine in combination with R-CHOP

R-CHOP
Decitabine in combination with R-CHOPDRUG

Decitabine in combination with R-CHOP

Decitabine in combination with R-CHOP

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Initial treatment of diffuse large B-cell lymphoma (DLBCL) confirmed by tumor histopathology with at least one lesion on either axis More than 1.5 cm, sufficient specimens for second-generation sequencing or single-cell sequencing;
  • Age \> 18 years old, \< 80 years old, gender unlimited;
  • EBER+ or peripheral blood EBV-DNA of pathological specimen was greater than 103copy/ml;
  • Patients judged by the investigator to have a life expectancy of at least 6 months;
  • The patient or his legal representative must provide written informed consent prior to any research special examination or procedure.
  • Signed written informed consent before screening.

You may not qualify if:

  • Have previously received systemic or local treatment including chemotherapy;
  • Previously received autologous stem cell transplantation;
  • Previous history of other malignant tumors, except skin basal cell carcinoma and cervical carcinoma in situ;
  • Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases and serious infectious diseases;
  • Lymphoma involves the central nervous system;
  • Primary mediastinal large B-cell lymphoma;
  • Left ventricular ejection fraction \< 50%;
  • Laboratory test values at the time of screening: (unless due to lymphoma);
  • Neutrophils \< 1.5 x 109/L;
  • Platelet \< 75 x 109/L;
  • ALT or AST were 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal;
  • creatinine levels higher than 1.5 times the upper limit of normal;
  • Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
  • Pregnant or lactating women;
  • Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

R-CHOP protocolDecitabine

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 16, 2026

Study Start

July 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2028

Last Updated

January 16, 2026

Record last verified: 2025-01

Locations

CN(1)