Decitabine added to R-CHOP for newly diagnosed EBV-positive diffuse large B-cell lymphoma
Compares R-CHOP with and without decitabine in adults newly diagnosed with EBV-positive lymphoma.
Plain-language title generated from the registry record
Registry title: A Multicenter, Prospective, Randomized, Controlled Study of Decitabine in Combination With R-CHOP for Initial Treatment of EBV+ Diffuse Large B-cell Lymphoma
Key facts
- Where
- Nanchang, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07348575, who can take part
Where in China
- The Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital of Nanchang University
- Trial code
- NCT07348575
- Record updated
- 16 January 2026
- Original description
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).Read full original descriptionShow less
A Multicenter, Prospective, Randomized, Controlled Study of Decitabine in Combination With R-CHOP for Initial Treatment of EBV+ Diffuse Large B-cell Lymphoma
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).
Inclusion: 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: Have previously received systemic or local treatment including chemotherapy; Previously received autologous stem cell transplantation; Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study; 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; Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol; 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; 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; Lymphoma involves the central nervous system; Primary mediastinal large B-cell lymphoma; Pregnant or lactating women.