CR-CHOP+X in Previously Untreated DEL

Launched by RUIJIN HOSPITAL · Nov 21, 2024

Keywords

ClinConnect Summary

This clinical trial, called CR-CHOP+X, is investigating a new treatment approach for patients with a type of cancer known as diffuse large B-cell lymphoma (DLBCL). Specifically, the study is looking at how well a combination of chemotherapy and targeted drugs works for patients who have a specific form of this cancer, called double-expressor lymphoma (DEL), and who have not received treatment before. The trial aims to see if this new treatment regimen is effective and safe for patients with DEL.

To participate in this trial, patients must be between 18 and 75 years old and have a confirmed diagnosis of DLBCL that meets certain criteria, including specific levels of certain proteins in their cancer cells. Participants must have no history of other cancers and should have a good overall health status. Those who join the trial will receive the new treatment and be closely monitored by the research team to track their health and how well the treatment is working. This trial is currently recruiting participants, so if you or someone you know might be eligible, it could be a valuable opportunity to explore new treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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.