Could a chemo booster tame a tough lymphoma?
NCT ID NCT07348575
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether adding decitabine to standard chemotherapy (R-CHOP) helps people with a specific, aggressive lymphoma tied to the Epstein-Barr virus. About 80 newly diagnosed patients will be randomly assigned to get either the new combo or standard treatment alone. Researchers will track how long participants live without their cancer getting worse over two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- decitabine combined with R-CHOP (a chemotherapy regimen)
- What this could lead to
- If successful, this could improve long-term control of EBV+ diffuse large B-cell lymphoma, potentially increasing the chance of staying cancer-free for two years.
- What could go wrong
- This is a mid-stage trial with only 80 participants, so results may not apply to all patients. Adding decitabine could also increase side effects like low blood counts or infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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; 2. Age \> 18 years old, \< 80 years old, gender unlimited; 3. EBER+ or peripheral blood EBV-DNA of pathological specimen was greater than 103copy/ml; 4. Patients judged by the investigator to have a life expectancy of at least 6 months; 5. The patient or his legal representative must provide written informed consent prior to any research special examination or procedure. 6. Signed written informed consent before screening. Exclusion Criteria: 1. Have previously received systemic or local treatment including chemotherapy; 2. Previously received autologous stem cell transplantation; 3. Previous history of other malignant tumors, except skin basal cell carcinoma and cervical carcinoma in situ; 4. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases and serious infectious diseases; 5. Lymphoma involves the central nervous system; 6. Primary mediastinal large B-cell lymphoma; 7. Left ventricular ejection fraction \< 50%; 8. Laboratory test values at the time of screening: (unless due to lymphoma); 1. Neutrophils \< 1.5 x 109/L; 2. Platelet \< 75 x 109/L; 3. 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; 4. creatinine levels higher than 1.5 times the upper limit of normal; 9. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol; 10. Pregnant or lactating women; 11. 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. 12. Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
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