NCT07074470View on ClinicalTrials.gov

Combination Regimen of Teniposide, PD-1 Monoclonal Antibody and Selinixor for Patients With Relapsed or Refractory PCNSL

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 2, 2025

Primary Completion Date

January 2, 2030

Study Completion Date

January 2, 2032

Conditions
Primary Central Nervous System Lymphoma (PCNSL)
Interventions
DRUG

Induction therapy-2 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor)

2 cycles of VPX regimen (21days per cycle) Teniposide: intravenous drip, 50mg d1-3; PD-1 monoclonal antibody: intravenous drip, 200mg d1; Selinixor: take 40mg orally, W1，60mg，W2，40mg biw，W3，cycle 1； 40mg， biw，cycle 2

PROCEDURE

Consolidation therapy with ASCT after TB (Thiotepa plus Busulfan) preconditioning

"TB preconditioning:~Thiotepa intravenous drip 300mg/m2 d-6-d-5; Busulfan: intravenous drip, 0.8mg/kg q6h d-4--d2; followed by autologous peripheral stem cells infusion at day 0"

DRUG

Consolidation therapy-4 cycles of VPX (Teniposide, PD-1 monoclonal antibody plus Selinixor)

4 cycles of VPX regimen (21days per cycle) Teniposide: intravenous drip, 50mg d1-3; PD-1 monoclonal antibody: intravenous drip, 200mg d1; Selinixor: take 40mg orally biw, cycle 3-6；

RADIATION

Consolidation therapy-whole brain radiation therapy

whole brain radiotherapy: CTV1: 20-30Gy/10fractions GTVp: 25-40Gy/10fractions

DRUG

Maintenance treatment-PD-1 monoclonal antibody

PD-1 monoclonal antibody for up to 2 years intravenous infusion, 200mg d1 (21days per cycle)

Trial Locations (1)

215006

RECRUITING

The First Affiliated Hospital of Soochow University, Suzhou

All Listed Sponsors
lead

The First Affiliated Hospital of Soochow University

OTHER