Not Yet RecruitingPhase 2

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

82 participantsStarted 2024-11-01

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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;
✓. The subjects tested positive for MYC in primary or pre-transplant lymphoma lesions;
✓. 18≤ age ≤65 years old, male or female;
✓. ECOG score 0-2;
✓. No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) :
✓. White blood cell count ≥3.0×109/L, absolute neutrophil count ≥1.5×109/L, Hemoglobin ≥90g/L, platelet ≥75×109/L;
✓. Total bilirubin ≤1.5× upper normal value (ULN);
✓. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN; Bilirubin ≤1.5× ULN

Exclusion criteria

✕. Previously received autologous hematopoietic stem cell transplantation;
✕. Suffering from serious complications or severe infection;
✕. Previous treatment with selinexor;
✕. Central nervous system lymphoma was excluded;
✕. A history of other malignant tumors within 5 years, excluding early tumors treated for curative purposes;
✕. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.;
✕. HBsAg, HCV or HIV positive. Positive HBV and HCV serology is allowed, but DNA/RNA testing must be negative;
✕. Left ventricular ejection fraction ≦ 50%;

What they're measuring

Progression free survival

Timeframe: Baseline up to data cut-off (up to approximately 2 years)

Trial details

NCT IDNCT06652139

SponsorRuijin Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-01

Contact for this trial

Zhao Weili, Professor

+862164370045 zwl_trial@163.com

View on ClinicalTrials.gov More Diffuse Large B Cell Lymphoma trials