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

NCT ID: NCT06652139

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2028-11-01

Brief 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.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

selinexor combined with BEAM pretreatment regimen

Patients in this arm will receive selinexor combined with BEAM (carmustine, etoposide, cytarabine and melphalan) as pretreatment regimen of ASCT.

Group Type: EXPERIMENTAL

selinexor combined with BEAM regimen

Intervention Type: DRUG

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

BEAM pretreatment regimen

Patients in this arm will receive BEAM (carmustine, etoposide, cytarabine and melphalan) as pretreatment regimen of ASCT.

Group Type: ACTIVE_COMPARATOR

BEAM regimen

Intervention Type: DRUG

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

Interventions

selinexor combined with BEAM regimen

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

Intervention Type: DRUG

BEAM regimen

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

Intervention Type: DRUG

Other Intervention Names

SINE+BEAM; BEAM

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Weili

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zhao Weili, Professor

Role: CONTACT

zwl_trial@163.com

+862164370045

Shen Yige, Professor

Role: CONTACT

13735204096@163.com

+862164370045

Other Identifiers

SINE+BEAM

Identifier Type: -

Identifier Source: org_study_id