RecruitingPhase 2NCT06737250

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


Sponsor

NOBO Medicine

Enrollment

33 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — poseltinib (NB02), rituximab, and lenalidomide — for patients with primary central nervous system lymphoma (PCNSL), a rare brain lymphoma that has come back or stopped responding to treatment. **You may be eligible if...** - You are between 19 and 80 years old - You have been diagnosed with CD20-positive primary CNS lymphoma (PCNSL), confirmed by biopsy - Your lymphoma has progressed or returned after prior remission treatment, radiation, or autologous stem cell transplant - You have had no more than two prior systemic treatments and no more than one prior radiation treatment **You may NOT be eligible if...** - You have had more than two prior systemic treatments - Your cancer cells do not express CD20 - You are in very poor health or have serious organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGR2P -> 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


Locations(10)

Kosin University Gospel Hospital

Busan, South Korea

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Korea National Cancer Center

Ilsan, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Asan Medical Center

Seoul, South Korea

Catholic univ of Yeouido St Mary's Hospital

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Ulsan University Hospital

Ulsan, South Korea

View Full Details on ClinicalTrials.gov

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NCT06737250


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