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Trial Title:
Plasma cfDNA Testing Guiding the Treatment Decisions of DLBCL
NCT ID:
NCT06289959
Condition:
Lymphoma, Large B-Cell, Diffuse
Conditions: Official terms:
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Conditions: Keywords:
cfDNA
therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
cfDNA
Description:
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.
Arm group label:
Group1（Plasma cfDNA-negative patients）
Arm group label:
Group2（plasma cfDNA-positive patients）
Arm group label:
Group3（plasma cfDNA-positive patients）
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.
Detailed description:
This study is initiated by researchers and is a prospective, single-center, randomized,
clinical controlled study. The study subjects are newly diagnosed DLBCL patients with
plasma cfDNA positivity (defined as positive for point mutations, CNV, IgH-related
fusion, or IG clonal rearrangement). After achieving complete metabolic remission (Lugano
response assessment criteria) following 6 cycles of R-CHOP-like chemotherapy, patients
undergo plasma cfDNA testing upon enrollment. Plasma cfDNA-negative patients (Group 1)
continue to receive monotherapy with rituximab for 2 cycles, while plasma cfDNA-positive
patients are randomly assigned to Group 2 and Group 3. Group 2 patients continue
monotherapy with rituximab for 2 cycles, and Group 3 patients receive the original
regimen for 2 cycles. Plasma cfDNA testing is performed again for all three groups after
completion of the entire treatment. Patient progression-free survival (PFS) is observed
for 2 years. After treatment completion, follow-up visits are scheduled every 3 months
for a total of 24 months.
Research Objective: 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.
Expected Results: Determining subsequent treatment based on plasma cfDNA MRD results at
the end of DLBCL patient treatment is expected to aid in identifying high-risk patients
for early relapse and improving their prognosis.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215000
Country:
China
Contact:
Last name:
Bingzong Li, Professor
Phone:
0086-13776054037
Email:
lbzwz0907@hotmail.com
Start date:
February 25, 2024
Completion date:
January 1, 2029
Lead sponsor:
Agency:
Second Affiliated Hospital of Soochow University
Agency class:
Other
Source:
Second Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06289959
