CD-RCHOP in ND DLBCL With a Combination of TP53 Mutation and Del(17p)

Launched by RUIJIN HOSPITAL · Dec 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for patients with a type of cancer called diffuse large B-cell lymphoma (DLBCL) who have specific genetic changes known as TP53 mutations and deletion of 17p (del(17p)). The study will involve participants who are newly diagnosed with DLBCL and have a certain score on a health assessment scale, meaning they have a good chance of tolerating treatment. Eligible participants must be between 18 and 75 years old, have not received previous cancer treatments, and have a life expectancy of at least six months.

If you or someone you know qualifies for this trial, they would first receive a standard treatment called R-CHOP for one cycle, followed by five more cycles that combine R-CHOP with two other medications, chidamide and decitabine. This trial is currently not recruiting participants, so it’s important to check back later for updates. Overall, the goal of the study is to see if this new combination treatment can improve outcomes for patients with this challenging form of lymphoma.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 1. Have previously received systemic or local treatment including chemotherapy;
• • 2. Previously received autologous stem cell transplantation;
• • 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;
• • 5. Primary central nervous system lymphoma;
• • 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
• • 8. Other concurrent and uncontrolled medical conditions that the investigator believes will affect patient participation in the study.
• • 9. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
• • 10. Pregnant or lactating women;
• • 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.