Selinexor Combined With R-GDP Regimen for TP53-altered R/R DLBCL
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
To evaluate the efficacy and safety of selinexor combined with R-GDP regimen in the treatment of patients with TP53-altered relapsed or refractory B-cell lymphoma.
Eligibility criteria
Qualifiers
Age≥18
Pathologically confirmed primary DLBCL or previously diagnosed indolent lymphoma (e.g., follicular lymphoma) transformation to DLBCL with TP53 deletion or mutation confirmed by FISH or next-generation sequencing.
Received at least 1 but no more than 3 previous lines of systemic therapy for DLBCL, and was relapsed or refractory to the last line of therapy Salvage chemoimmunotherapy and subsequent stem cell transplantation are considered the same first-line systemic therapy Maintenance therapy will not be counted separately as first-line systemic therapy Radiotherapy for curative treatment of localized DLBCL lesions does not count as first-line systemic therapy
Presence of measurable positron-emission tomography (PET) -positive lesions with at least one lymph node lesion long diameter (LDi) > 1.5 cm or an extra-nodal lesion LDi > 1 cm (according to the Lugano classification, 2014 version)
Disqualifiers
Prior treatment with selinexor or another XPO1 inhibitor
There are contraindications to any drug in the combination therapy
Receipt of any standard or investigational anti-DLBCL therapy <21 days before C1D1 (including non-palliative radiotherapy, chemotherapy, immunotherapy, radioimmunotherapy, or any other anticancer therapy) (Palliative radiotherapy for non-target lesions was allowed)
Undergone major surgery <14 days before C1D1
Trial design
Treatments tested in this trial
- SR-GDP
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov