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Enrolling by invitation NCT07348575

A Multicenter, Prospective, Randomized, Controlled Study of Decitabine in Combination With R-CHOP for Initial Treatment of EBV+ Diffuse Large B-cell Lymphoma

Phase III Interventional Lymphoma, Large-Cell, Diffuse

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: R-CHOP, Decitabine in combination with R-CHOP.
Who it may be relevant to
Registry conditions: Lymphoma, Large-Cell, Diffuse. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Drug R-CHOP
    Decitabine in combination with R-CHOP
  • Drug Decitabine in combination with R-CHOP
    Decitabine in combination with R-CHOP

Primary outcome measures

  • 2-year progression-free survival [Time frame: 2 year]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (polymerase chain Reaction \[PCR\] showed positive results). If the HbsAg test result is positive, HBV DNA test should be performed, if the HBV DNA<103IU/ml, can be enrolled. If HBsAg test results are negative, but HBcAb test is positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA<103 IU/ml can be enrolled. If the patient's HCV antibody is positive, the HCV RNA is detected by PCR. If positive, the exclusion criteria are met.
  • Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of Nanchang University — Nanchang

Identifiers

NCT: NCT07348575 · BR/AF/SG-05/1.1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗