Clinical Trials in China / NCT06289959
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Plasma cfDNA Testing Guiding the Treatment Decisions of DLBCL
NCT06289959 · tracked via the Priya Life Science China tracker
Condition(s) studied
Lymphoma, Large B-Cell, Diffuse
Investigational drug(s) / intervention(s)
cfDNA
cfDNA: After achieving complete metabolic remission (Lugano response assessment criteria) following 6 cycles of R-CHOP-like chemotherapy, patients undergo plasma cfDNA testing upon enrollment，and the follow-up treatment plans are based on cfDNA results.
Study summary
A prospective, single center, randomized, clinical controlled study to evaluate the efficacy and prognosis differences between precision treatment based on plasma cfDNA testing results and the current conventional diagnostic and treatment practices for DLBCL patients.
Eligibility
Inclusion Criteria:
* Age ≥ 18 years, gender not specified.
* Newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL) confirmed by histopathological examination. Patients should test positive for plasma cfDNA before treatment (defined as positive for point mutations, CNV, IgH-related fusion, or IG clonal rearrangement) and achieve complete metabolic remission after 6 cycles of R-CHOP chemotherapy (evaluated by Lugano response assessment criteria).
* Patients for whom the researcher predicts a life expectancy of \>6 months.
* Signed informed consent form.
Exclusion Criteria:
* Patients who have undergone autologous stem cell transplantation.
* Patients with a history of other malignant tumors, except for basal cell carcinoma of the skin or in situ cervical cancer.
* Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, and other such conditions;
* Primary central nervous system lymphoma.
* Patients with mental illness or others known or suspected to be unable to fully comply with the study protocol.
* Pregnant or lactating women.
* HbsAg-positive patients who need to undergo HBV-DNA testing and can only be included if they seroconvert. Additionally, if the HbsAg test is negative but the HBcAb test is positive (regardless of HbsAb status), HBV-DNA testing is also required. If the result is positive, inclusion is possible only after seroconversion.
* HIV-infected individuals.
* Other concurrent and uncontrolled diseases that researchers believe may affect the medical condition of patients participating in the study.
Primary outcome measure(s)
- Progression-free survival（PFS） — From date of randomization until the date of first documented progression or date of death from any cause,whichever came first，assessed up to 24 months.
Evaluate the PFS among three groups with different treatment practices for diffuse large B-cell lymphoma (DLBCL) patients.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu |
More Second Affiliated Hospital of Soochow University trials in China
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06289959 on ClinicalTrials.gov ↗ ← All trials in China