Plasma cfDNA Testing Guiding the Treatment Decisions of DLBCL

Launched by SECOND AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Mar 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to guide treatment decisions for patients with diffuse large B-cell lymphoma (DLBCL), a type of cancer that affects the lymphatic system. Researchers want to see if using a test that looks for certain genetic markers in the blood (called plasma cfDNA testing) can help doctors choose more effective treatments compared to the standard methods currently used. The trial aims to find out if this personalized approach can lead to better outcomes for patients.

To participate in the trial, individuals must be at least 18 years old and have recently been diagnosed with DLBCL, confirmed by a medical examination. They also need to test positive for specific genetic markers in their blood before starting treatment and show signs of improvement after receiving six cycles of standard chemotherapy. Participants will be closely monitored throughout the study, and their experiences will help researchers understand how well this new approach works. It’s important to note that certain patients, such as those with other serious health conditions or specific medical histories, may not be eligible to join the trial.

Gender

ALL

Eligibility criteria

• 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.