Comparison of MODIFIED progression-free survival (Modified-PFS) in high-dose rituximab(500mg/m²) plus CHOP versus standard-dose rituximab plus CHOP in previously untreated(TN) stage III-IV male DLBCL patients
This study is a multicenter, randomized, controlled Phase III clinical trial that
primarily evaluates the modified progression-free survival (MODIFIED-PFS) in previously
untreated male DLBCL patients treated with high-dose rituximab (500mg/m²) combined with
the CHOP regimen compared to standard-dose rituximab combined with the CHOP regimen.
After signing the informed consent and before randomization, all participants must
provide sufficient tumor tissue biopsy samples for confirmation of DLBCL via central
laboratory tests such as HE staining and IHC. Eligible participants are randomized in a
1:1 ratio to either the experimental group (rituximab 500 mg/m2) or the control group
(rituximab 375 mg/m2) and will receive 6 cycles of R-CHOP treatment (21 days per cycle),
followed by 2 additional cycles of maintenance therapy with rituximab (21 days per
cycle).
Drug: Rituximab
Patients will be randomized to receive either rituximab 500 mg/m2 or rituximab 375 mg/m2
for six cycles of R-CHOP (21 days per cycle), followed by two maintenance cycles of
rituximab (21 days per cycle).
Key Inclusion Criteria:
1. age <75y, male patients
2. According to the 2017 Revised WHO Classification criteria for lymphoma, the subject
was diagnosed with DLBCL
3. According to Ann Arbor staging, patients were classified as stage III-IV patients
4. No previous anti-tumor systemic therapy or local radiation therapy for DLBCL
5. Expected survival ≥6 months
6. Have sufficient coagulation function and liver and kidney function
7. Haver sufficient bone marrow function
8. All patients should take medically approved contraceptive measures within 12 months
after rituximab administration (specific circumstances should follow the listed drug
label)
9. Subjects were enrolled voluntarily, signed informed consent, and followed the
experimental treatment protocol and visit plan
Key Exclusion Criteria:
1. Subjects assessed by the investigator to be intolerant to the R-CHOP regimen and/or
any drug therapy;
2. Any previous anti-lymphoma systemic therapy or local radiation therapy
3. Consider patients with lymphoma involving the central nervous system (CNS) or
diagnosed with primary CNS lymphoma (PCNSL); The diagnosis was primary mediastinal
large B-cell lymphoma (PMBL)
4. Previously received organ transplantation or hematopoietic stem cell transplantation
5. Had received major surgery or major trauma within 4 weeks before the first
medication (or before randomization), and had participated in clinical trials of
non-anti-tumor drugs or medical devices within 4 weeks
6. Have had malignant tumors other than the indications targeted in this study in the
past three years
7. Participants with any serious and/or uncontrolled systemic disease who are
determined by the investigator to be unsuitable for participation in the study
8. Major cardiovascular disease occurred within 6 months before the first medication
(or before randomization)
9. Any conditions that affect the patient's ingestion of the drug, as well as
conditions that seriously affect the absorption or pharmacokinetic parameters of the
drug in the trial, including difficult to control nausea and vomiting, short bowel
syndrome, etc.
10. Subjects who received live or attenuated vaccine within 4 weeks prior to initial
administration (or prior to randomization) or planned to receive live vaccine during
the study period or 4 weeks after the end of study treatment
11. A hemorrhagic disease (such as von Willebrand disease or hemophilia A, hemophilia B,
etc.) or according to the judgment of the investigator has a clear bleeding tendency
12. have a serious peripheral nervous system or central nervous system disease.
13. Warfarin or other vitamin K antagonists are required during the study
14. There is an autoimmune disease that cannot be controlled or requires treatment
within 4 weeks prior to the first dose (or prior to randomization)
15. Doxorubicin has been used in the past ≥150 mg/m2
16. The investigator believes that the subjects have other conditions that are not
suitable for participation in this experiment.
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