NCT06652139

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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
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

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-11-01
• Completion: 2028-11-01
• First posted: 2024-10-22
• Last updated: 2024-10-22