Zanubrutinib Combined With BEAM for ASCT in Relapsed and Refractory DLBCL

Launched by RUIJIN HOSPITAL · Oct 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a type of blood cancer. Researchers want to see if combining a medication called zanubrutinib with a chemotherapy regimen known as BEAM (which includes drugs that help prepare the body for a procedure called autologous stem cell transplantation, or ASCT) is effective and safe for patients. The trial is not yet recruiting participants, but it aims to enroll individuals aged 18 to 65 who have been diagnosed with DLBCL and have not responded well to previous treatments.

To be eligible for this trial, participants must show that their cancer has been confirmed through a specific testing method and that they have achieved at least a partial response to previous treatments. They should also be generally healthy, without major organ issues or serious infections. Participants will need to provide written consent to join the study. If you or someone you know is considering participation, it’s important to discuss this with a healthcare provider to understand the potential benefits and risks involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. According to world Health Organization (WHO) classification of disease, diffuse large B-cell lymphoma was confirmed by histology, CR or PR after second-line and above treatment;
• • 2. 18≤ age ≤65 years old, male or female;
• • 3. ECOG score 0-2;
• 4. No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) :
• • 1. White blood cell count ≥3.0×109/L, absolute neutrophil count ≥1.5×109/L, Hemoglobin ≥90g/L, platelet ≥75×109/L;
• • 2. Total bilirubin ≤1.5× upper normal value (ULN);
• • 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN; Bilirubin ≤1.5× ULN
• • 4. Creatinine clearance was 44-133 mmol/L;
• • 5. No cardiac dysfunction;
• • 6. Life expectancy over 3 months;
• • 7. The subject or his/her legal representative must provide written informed consent prior to conducting a special study examination or procedure.
• Exclusion Criteria:
• • 1. Previously received autologous hematopoietic stem cell transplantation;
• • 2. Suffering from serious complications or severe infection;
• • 3. Previous treatment with selinexor;
• • 4. Central nervous system lymphoma was excluded;
• • 5. A history of other malignant tumors within 5 years, excluding early tumors treated for curative purposes;
• • 6. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.;
• • 7. HBsAg, HCV or HIV positive. Positive HBV and HCV serology is allowed, but DNA/RNA testing must be negative;
• • 8. Left ventricular ejection fraction ≦ 50%;
• • 9. Laboratory test value during screening;
• • ① Neutrophils \<1.5×109/L; Platelet \<75×109/L;
• • ② Bilirubin was 1.5 times higher than the normal upper limit, transaminase was 2.5 times higher than the normal upper limit;
• • ③ The creatinine level is higher than 1.5 times the upper limit of normal value;
• • 10. Other concurrent and uncontrolled medical conditions considered by the investigator would affect the patient's participation in the study;
• • 11. Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;
• • 12. Pregnant or lactating women;
• • 13. The researcher judged that the patients were not suitable for this study.