Pirtobrutinib Combined With BEAM for ASCT in Relapsed and Refractory DLBCL

A Multicenter, Single-Arm Clinical Study of Pirtobrutinib Combined With Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preconditioning Regimen for ASCT in Relapsed and Refractory DLBCL

This trial is a prospective, multi-center, single-arm clinical research. The intention is to evaluate the efficacy and safety of pirtobrutinib combined with BEAM as a pretreatment regimen for ASCT in relapsed and refractory DLBCL patients.

A total of 28 patients with relapsed/refractory DLBCL are planned to be enrolled in this trial. They will receive pirtobrutinib in combination with the BEAM regimen as conditioning therapy, followed by ASCT. The study comprises a screening period, a treatment period (days -8 to -2, 7 days in total), and a 2-year follow-up period after transplantation.

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 ≤70 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. Central nervous system lymphoma was excluded;

4. A history of other malignant tumors within 5 years, excluding early tumors treated for curative purposes;

5. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.;

6. HBsAg, HCV or HIV positive. Positive HBV and HCV serology is allowed, but DNA/RNA testing must be negative;

7. Left ventricular ejection fraction ≦ 50%;

8. 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;

9. Other concurrent and uncontrolled medical conditions considered by the investigator would affect the patient's participation in the study;

10. Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;

11. Pregnant or lactating women;

12. The researcher judged that the patients were not suitable for this study.