Newly diagnosed high-risk diffuse large B-cell lymphoma
Conditions
Interventions
Observation treatment group:None
Observation control group:None
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histological pathology confirmed diffuse large B-cell lymphoma, and CD20 was positive; 2. At least one of the following adverse factors must be met: (1) Pathologically confirmed double expression of MYC and BCL2 (immunohistochemistry: MYC>=40%, BCL2>=50%); (2) IPI>=3 or aaIPI>=2, and at least one of the following: tumor diameter>=6cm; Extranodal involvement of>=1 site; Lymphoma affects one of the following special sites: the central nervous system, testicles, breasts, adrenal glands, and uterus; 3. Complete remission (CR) was achieved after initial induction therapy; 4. Age>=18 years old and1.
Exclusion criteria
Exclusion criteria: 1. Complete remission was not achieved after the initial induction therapy ended; 2. Double strike (MYC and BCL2 rearrangement) or positive TP53 mutation; 3. Patients who have received organ transplantions; 4. Patients with uncontrolled coagulation disorders or active bleeding; 5. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases (including left ventricular ejection fraction 1.5 times the normal value, ALT/AST > 2.5 times the normal value or ALT/AST > 5 times the normal value in patients with liver invasion), abnormal kidney function (serum creatinine > 1.5 times the normal value); 8. For patients with positive HbsAg, HBV DNA testing is required. If the HBV DNA is less than 103IU/ml, they can be enrolled. If the HBsAg test result is negative but the HBcAb test is positive (regardless of the HBsAb status), HBV-DNA test is also required. If the HBV DNA is less than 103IU/ml, the group can be enrolled; 9. HIV-infected individuals; 10. Currently undergoing other anti-tumor treatments (lymphoma or other types of tumors); 11. Patients who are addicted to drugs or have long-term alcohol abuse, which affects the evaluation of treatment outcomes; 12. Patients with mental illness or other patients known or suspected of not fully complying with the research protocol; 13. Continuous treatment with potent and medium-potency CYP3A inhibitors or CYP3A inducers is required. Patients who have taken strong or moderate CYP3A inhibitors or inducers within 7 days before the first administration of the study drug (or have taken these drugs for less than 5 half-lives) are not eligible for enrollment; 14. Inability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction; 15. Other concurrent and uncontrolled medical conditions that the researchers believe will affect patients' participation in the study. Any life-threatening disease, medical condition or organ system dysfunction that the researchers believe may endanger the safety of the subjects, interfere with the absorption or metabolism of oral targeted drugs, or pose an excessive risk to the study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression-free-survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactXie Wanzhuo
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed