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Plasma cfDNA Testing Guiding the Treatment Decisions of DLBCL

ConditionLymphoma, Large B-Cell, Diffuse
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Soochow University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • cfDNA

    Diagnostic test

    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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Group1（Plasma cfDNA-negative patients）Active comparator 1 intervention
Group B: Group2（plasma cfDNA-positive patients）Experimental treatment 1 intervention
Group C: Group3（plasma cfDNA-positive patients）Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival（PFS）

Evaluate the PFS among three groups with different treatment practices for diffuse large B-cell lymphoma (DLBCL) patients.

Time frame
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.

Secondary outcomes

1

Sensitivity, and specificity of plasma cfDNA in DLBCL patients

Evaluate the sensitivity, and specificity of plasma cfDNA testing at the end of treatment in DLBCL

Time frame
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.
2

Overall survivals(OS)

overall survival in DLBCL patients.

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: