Selinexor Combined With BEAM for ASCT in R/R DLBCL With MYC Positive

Trial Title: Selinexor Combined With BEAM for ASCT in R/R DLBCL With MYC Positive

NCT ID: NCT06652139

Condition: Diffuse Large B Cell Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Cytarabine
Carmustine
Melphalan
Etoposide

Conditions: Keywords:
Diffuse large B cell lymphoma
Autologous stem cell transplantation
Selinexor
BEAM

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: selinexor combined with BEAM regimen
Description: Selinexor: 60mg po D-10, D-7 and D-4 Carmustine: 300mg/m2 ivgtt D-8 Etoposide: 100mg/m2/d ivgtt q12h D-7-D-4 Cytarabine: 200mg/m2/d ivgtt q12h D-7-D-4 Melphalan: 140mg/m2 ivgtt D-3-D2
Arm group label: selinexor combined with BEAM pretreatment regimen

Other name: SINE+BEAM

Intervention type: Drug
Intervention name: BEAM regimen
Description: Carmustine: 300mg/m2 ivgtt D-8 Etoposide: 100mg/m2/d ivgtt q12h D-7-D-4 Cytarabine: 200mg/m2/d ivgtt q12h D-7-D-4 Melphalan: 140mg/m2 ivgtt D-3-D2
Arm group label: BEAM pretreatment regimen

Other name: BEAM

Summary: To evaluate the efficacy and safety of selinexor combined with BEAM pretreatment regimen in ASCT of recurrent and refractory DLBCL patients with immunohistochemical positive for MYC

Detailed description: This trial included 82 patients, who were randomly divided into pre-treatment with selinexor combined with BEAM regimen (experimental group) or BEAM regimen (control group) according to 1:1, and then underwent ASCT therapy. The trial included a screening period, a treatment period (2 weeks before and after transplantation), and a follow-up period (2 years after autologous transplantation). At 3, 6, 9 and 18 months after ASCT, blood routine, blood biochemistry, B-ultrasound of liver, bile, pancreas, spleen and lymph node, and whole body enhanced CT were performed. At 1 and 2 years after ASCT, blood routine, blood biochemistry, and whole body PET-CT evaluation were performed until the end of the study.

Criteria for 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. The subjects tested positive for MYC in primary or pre-transplant lymphoma lesions; 3. 18≤ age ≤65 years old, male or female; 4. ECOG score 0-2; 5. 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; 6. No cardiac dysfunction; 7. Life expectancy over 3 months; 8. 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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Start date: November 1, 2024

Completion date: November 1, 2028

Lead sponsor:
Agency: Ruijin Hospital
Agency class: Other

Source: Ruijin Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06652139