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

Sponsor
Ruijin Hospital
Study ID
NCT06652139
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • selinexor combined with BEAM regimen — 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 regimen — 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

Study Details

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

Key Dates

Start date
Nov 1, 2024
Status verified
Oct 2024
Primary completion
Nov 1, 2026
Completion
Nov 1, 2028

Study Design

Enrollment
82 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Progression free survival [ Time Frame: Baseline up to data cut-off (up to approximately 2 years) ]

Central Contacts

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