Tests chemotherapy combined with targeted drugs in new lymphoma cases
Tests combined chemotherapy with targeted drugs in adults newly diagnosed with diffuse large B-cell lymphoma.
Plain-language title generated from the registry record
Registry title: CR-CHOP+X in Previously Untreated DEL
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06701357, who can take part
Where in China
- No. 197 Ruijin 2nd Road, Huangpu District, ShanghaiShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT06701357
- Record updated
- 30 December 2024
- Original description
This is a prospective, single-arm, open-label phase II clinical trial that evaluates the efficacy and safety of CR-CHOP regimen combined with different targeted drugs based on different molecular subtypes in newly diagnosed DEL patients.Read full original descriptionShow less
A Prospective, Open-label Phase II Study of Chidamide Plus R-CHOP + X in Previously Untreated Diffuse Large B-cell Lymphoma with Double Expression of MYC and BCL2.
This is a prospective, single-arm, open-label phase II clinical trial that evaluates the efficacy and safety of CR-CHOP regimen combined with different targeted drugs based on different molecular subtypes in newly diagnosed DEL patients.
Inclusion: 1. Histologically confirmed diffuse large B-cell lymphoma with CD20 positive; 2. MYC and BCL2 are expressed simultaneously, WHO immunohistochemical standards: MYC≥40%, BCL2 ≥50%; 3. Age ≥ 18 years old, ≦75 years old; 4. ECOG physical status score of 0, 1 or 2; 5. No previous history of malignant tumors; No other tumors occurred simultaneously; 6. Patients judged by the investigator to have a life expectancy of at least 6 months; 7. The patient or his legal representative must provide written informed consent prior to any research special examination or procedure; 8. International prognostic Index (IPI) >1 score.
Exclusion: 1. Have previously received systemic or local treatment including chemotherapy; 2. Previously received autologous stem cell transplantation; 8. Other concurrent and uncontrolled medical conditions that the investigator believes will affect patient participation in the study; 3. Previous history of other malignant tumors, except skin basal cell carcinoma and cervical carcinoma in situ; 4. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases; 9. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol; 11. People living with HIV; 12. Patients with positive HbsAg test results need to undergo HBV DNA test, and can be enrolled before turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV DNA test should also be performed. If the result is positive, the treatment should also be negative before admission; 6. Left ventricular ejection fraction ≤ 50%; 7. Laboratory test values at the time of screening (unless due to lymphoma): A. Neutrophils <1.5*109/L; B. Platelet <75*109/L; C. ALT or AST were 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal; D. Creatinine levels higher than 1.5 times the upper limit of normal; 5. Primary central nervous system lymphoma; 10. Pregnant or lactating women.