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NCT07774299

PHASE2

Pirtobrutinib Combined With BEAM for ASCT in Relapsed and Refractory DLBCL

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08-25

Completion Date

2029-08-25

Last Updated

2026-08-19

Healthy Volunteers

Conditions

DLBCL

Interventions

DRUG

pirtobrutinib combined with BEAM

pirtobrutinib 200mg oral qd D-8-D-2; camustine: 300mg/m2 vgtt qd D-8; etoposide: 100mg/m2/d vgtt q12h D-7-D-4; cytarabine: 200mg/m2/d vgtt q12h D-7-D-4 melphalan: 70mg/m2 vgtt qd D3-D-2.

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.