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Trial Title:
Molecular Subtype-Guided R-CHOP-MTX±Zanubrutinib Treatment in Newly Diagnosed DLBCL Patients with Central Nervous System Involvement
NCT ID:
NCT06594432
Condition:
Diffuse Large B Cell Lymphoma (DLBCL)
Conditions: Official terms:
Lymphoma, Large B-Cell, Diffuse
Prednisone
Cyclophosphamide
Vincristine
Rituximab
Doxorubicin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
R-CHOP+Z+MTX
Description:
After receiving 1 cycle of pre-treatment with the R-CHOP regimen, patients with CSF-ctDNA
(+) and MCD, BN2, and N1 subtypes will receive 5 cycles of R-CHOP combined with MTX +
Zanubrutinib, followed by 1 cycle of R-MTX-Zanubrutinib.
After completing the above induction therapy, Patients with negative CSF-ctDNA results
will continue with one more cycle of Rituximab. For patients with positive CSF-ctDNA
results, the investigator will decide to continue treatment with Rituximab one more cycle
combined with Temozolomide, Pomalidomide, or Lenalidomide, etc., until CSF-ctDNA turns
negative.
Each combined regimen consists of a 21-day treatment cycle, and efficacy will be
evaluated every three treatment cycles.
Arm group label:
MCD, BN2, and N1 subtypes
Intervention type:
Drug
Intervention name:
R-CHOP+MTX
Description:
After receiving 1 cycle of pre-treatment with the R-CHOP regimen, patients with CSF-ctDNA
(+) and EZB, A53, and other gene subtypes will receive 5 cycles of R-CHOP combined with
MTX, followed by 1 cycle of R-MTX.
After completing the above induction therapy, Patients with negative CSF-ctDNA results
will continue with one more cycle of Rituximab. For patients with positive CSF-ctDNA
results, the investigator will decide to continue treatment with Rituximab one more cycle
combined with Temozolomide, Pomalidomide, or Lenalidomide, etc., until CSF-ctDNA turns
negative.
Each combined regimen consists of a 21-day treatment cycle, and efficacy will be
evaluated every three treatment cycles.
Arm group label:
EZB, A53, and other gene subtypes
Summary:
Evaluate the Efficacy and Safety of R-CHOP-MTX±Zanubrutinib in Newly Diagnosed Diffuse
Large B-Cell Lymphoma Patients with Central Nervous System Involvement, and Explore the
Efficacy Indicators of CSF-ctDNA.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 years and ≤80 years, regardless of gender;
2. Patients with pathologically confirmed, previously untreated diffuse large B-cell
lymphoma (DLBCL) who are CSF-ctDNA positive for secondary CNS lymphoma (SCNSL);
3. MRI or CT of the brain showing substantial lesions in the central nervous system;
patients with only meningeal lesions must have CSF cytology confirming lymphoma
cells and/or imaging findings consistent with CSF examination;
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3;
5. Organ function levels meeting the following requirements:Absolute neutrophil count
≥1.5×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥90g/L (if bone marrow is involved,
platelets ≥50×10^9/L).
6. Liver function: ALT and AST ≤2.5 times the upper limit of normal, total bilirubin ≤2
times the upper limit of normal.
8.Renal function: creatinine ≤1.5 times the upper limit of normal; creatinine clearance
rate ≥40 ml/min (assessed according to the Cockcroft-Gault formula or the estimated
glomerular filtration rate [eGFR] from the Modification of Diet in Renal Disease [MDRD]
formula).
9.Coagulation function: International Normalized Ratio (INR) ≤1.5 and activated partial
thromboplastin time (APTT) ≤1.5×ULN.
10.Expected survival time >3 months; 11.No radiotherapy, chemotherapy, or antibody
therapy within 3 weeks before medication; no targeted therapy within 10 days before
medication; 12.Female subjects of childbearing potential must agree to use effective
contraception during the study and for at least 90 days after the last dose of the study
drug. Male subjects must be sterilized, i.e., vasectomy, or use barrier methods, while
their female partners use the aforementioned effective contraception.
13.Signed written informed consent before trial screening.
Exclusion Criteria:
1. Previous treatment with BTK inhibitors;
2. Received targeted therapy within 10 days before starting the study drug, or systemic
chemotherapy, radiotherapy, or antibody therapy within 3 weeks before starting the
study drug;
3. Abnormal liver function (total bilirubin >2 times the normal value, ALT or AST
>2.5 times the normal value), abnormal renal function (serum creatinine >1.5
times the normal value);
4. Currently have clinically significant active cardiovascular disease, such as
uncontrolled arrhythmias, congestive heart failure, any grade 3 or 4 heart disease
as determined by the New York Heart Association (NYHA) functional classification, or
a history of myocardial infarction within 6 months before screening;
5. QTcF >450 msecs or other significant ECG abnormalities, including second-degree
type II atrioventricular (AV) block or third-degree AV block;
6. Previous chemotherapy with unresolved toxicity (toxicity not resolved to ≤ grade 1
according to NCI-CTCAE 5.0, except for alopecia, absolute neutrophil count (ANC),
and platelets);
7. Patients with active bleeding;
8. Patients with active infections or persistent fever within 14 days before enrollment
(excluding tumor-related fever);
9. Patients with active HBV, HCV, and HIV infections;
10. Patients with serous cavity effusion;
11. Patients who have not completed 4 weeks after major organ surgery;
12. Patients receiving strong inhibitors or strong inducers of cytochrome P450 family 3
subfamily A (CYP3A);
13. Pregnant or lactating women and patients of childbearing potential who are unwilling
to use contraception;
14. Patients with mental disorders/unable to obtain informed consent;
15. Patients who abuse drugs or have long-term alcoholism that affects the evaluation of
trial results;
16. Patients deemed unsuitable for participation in this study by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hematological Department, People's Hospital of Jiangsu Province
Address:
City:
Nanjing
Zip:
210029
Country:
China
Contact:
Last name:
Wei Xu, PhD
Phone:
+86-2568302182
Email:
xuwei10000@hotmail.com
Start date:
October 2024
Completion date:
June 2027
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06594432
