Clinical trial · Interventional
Selinexor Combined With BEAM for ASCT in R/R DLBCL With MYC Positive
A Single-center, Randomized Controlled Clinical Study of Selinexor Combined With BEAM as a Preconditioning Regimen for ASCT in Relapsed and Refractory Diffuse Large B-cell Lymphoma With MYC Positive
NCT06652139CI-TRIAL-00081815not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BEAM regimen | Drug | — | UNRESOLVED |
| selinexor combined with BEAM regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- selinexor combined with BEAM pretreatment regimen
- description
- Patients in this arm will receive selinexor combined with BEAM (carmustine, etoposide, cytarabine and melphalan) as pretreatment regimen of ASCT.
- interventionNames
- Drug: selinexor combined with BEAM regimen
- type
- ACTIVE_COMPARATOR
- label
- BEAM pretreatment regimen
- description
- Patients in this arm will receive BEAM (carmustine, etoposide, cytarabine and melphalan) as pretreatment regimen of ASCT.
- interventionNames
- Drug: BEAM regimen
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.