Clinical trial · Interventional
Plasma cfDNA Testing Guiding the Treatment Decisions of DLBCL
A Prospective, Single-Center, Randomized, Controlled Study Guiding the Treatment of Diffuse Large B-Cell Lymphoma Patients Based on Plasma cfDNA Testing
NCT06289959CI-TRIAL-00074653not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cfDNA | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Group1（Plasma cfDNA-negative patients）
- description
- Continue to receive monotherapy with rituximab （375mg/m2 q3w）for 2 cycles
- interventionNames
- Diagnostic Test: cfDNA
- type
- EXPERIMENTAL
- label
- Group2（plasma cfDNA-positive patients）
- description
- Continue monotherapy with rituximab （375mg/m2 q3w）for 2 cycles
- interventionNames
- Diagnostic Test: cfDNA
- type
- EXPERIMENTAL
- label
- Group3（plasma cfDNA-positive patients）
- description
- Receive the original regimen for 2 cycles（R-CHOP like）
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.