Tests a combination treatment in adults with newly diagnosed diffuse large B-cell lymphoma
Tests chidamide and decitabine with R-CHOP in adults with lymphoma and TP53 changes.
Plain-language title generated from the registry record
Registry title: CD-RCHOP in ND DLBCL With a Combination of TP53 Mutation and Del(17p)
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: NCT06750991, who can take part
Where in China
- No. 197 Ruijin 2nd Road, Huangpu District, ShanghaiShanghai, ChinaNo longer taking part
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
- NCT06750991
- Record updated
- 27 December 2024
- Original description
This was an open, multicenter clinical study of newly treated DLBCL patients with TP53 mutations and del(17p) with IPI>1. Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a standard-dose R-CHOP regimen.Read full original descriptionShow less
A Prospective, Open-label Phase II Study of Chidamide, Decitabine Plus R-CHOP in Previously Untreated Diffuse Large B-cell Lymphoma With a Combination of TP53 Mutation and Del(17p)
This was an open, multicenter clinical study of newly treated DLBCL patients with TP53 mutations and del(17p) with IPI>1. Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of R-CHOP, followed by the remaining 5 cycles courses of chidamide and decitabine combined with a standard-dose R-CHOP regimen.
Inclusion: 1. Histologically confirmed diffuse large B-cell lymphoma with CD20 positive; 2. Pathologically confirmed a combination of TP53 mutation and del(17p); 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; Creatinine levels higher than 1.5 times the upper limit of normal; 5. Primary central nervous system lymphoma; 10. Pregnant or lactating women.