NCT06737250

NB02 (Poseltinib) Combined Rituximab and Lenalidomide in R/R PCNSL

Open, Single Arm, Multicenter, Phase 2 Trial to Evaluate Efficacy and Safety of NB02 (Poseltinib) Combined with Rituximab and Lenalidomide As a Salvage Therapy for Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: NOBO Medicine · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

An Open, Single treatment arm, Multi-center, Prospective, Phase 2 Trial to Evaluate Efficacy and Safety of NB02 (Poseltinib) combined with Rituximab and Lenalidomide as a Salvage Therapy for Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma

Detailed description

For outpatients or inpatients who meet the criteria for subject selection, the study is conducted with patients who have given a sufficient explanation of the study and who voluntarily consented to participate in the study. Patients enrolled in the study receive a combination therapy of NB02, Rituximab and lenalidomide according to the criteria specified in the protocol. Induction(R2P) 21 days per cycles, 6 cycles * NB02 : 60mg BID PO, Day 1-21 * Rituximab 375mg/m2 DAY IV Day 1, 8, 15 at 1st cycle; D1 at 2nd to 6th cycles * Lenalidomide : 20mg QD PO, Day 1-14 Maintenance(RP) 21 days per cycles, until Progression * NB02 : 60mg BID PO, Day 1-21 * Lenalidomide : 20mg QD PO, Day 1-14

Conditions

• Primary CNS Lymphoma (PCNSL)

Interventions

Type	Name	Description
DRUG	R2P -> RP	Induction(R2P) 21 days per cycles, 6 cycles * NB02 : 60mg BID PO, Day 1-21 * Rituximab 375mg/m2 DAY IV Day 1, 8, 15 at 1st cycle; D1 at 2nd to 6th cycles * Lenalidomide : 20mg QD PO, Day 1-14 Maintenance(RP) 21 days per cycles, until Progression * NB02 : 60mg BID PO, Day 1-21 * Lenalidomide : 20mg QD PO, Day 1-14

Timeline

• Start date: 2024-11-25
• Primary completion: 2026-06-30
• Completion: 2027-12-31
• First posted: 2024-12-17
• Last updated: 2024-12-17

Locations

10 sites across 1 country: South Korea