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

NCT06737250 | Recruiting Phase 2 DMC

• 1 other identifier: 20240084640
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

Primary CNS Lymphoma (PCNSL)

Keywords

Refractory; Relapsed

Outcome Measures

Primary Outcomes (1)

• Overall Response (ORR) by IRC

  End Of Induction

  4 cycles (12 weeks)

Secondary Outcomes (6)

• Overall Response by Investigator (ORR)

  4 cycles (12 weeks)

• Overall Survival (OS)

  through study completion, an estimation of 2 years

• Progression Free Survival (PFS)

  through study completion, an estimation of 2 years

• Event Free Survival (EFS)

  through study completion, an estimation of 2 years

• Response Duration

  through study completion, an estimation of 2 years

Study Arms (1)

NB02 (Poseltinib) combined Rituximab and Lenalidomide

EXPERIMENTAL

Drug: R2P -> RP

Interventions

R2P -> RP DRUG

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

NB02 (Poseltinib) combined Rituximab and Lenalidomide

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient who voluntarily decided to participate and provided written consent after receiving an explanation of this clinical trial and the characteristics of the investigational drug.
• Adults aged 19 years or older and 80 years or younger.
• Patients diagnosed histopathologically with CD20-positive primary central nervous system lymphoma (PCNSL).
• Patients with confirmed disease progression or treatment resistance after remission induction therapy, radiotherapy, or autologous transplantation, with no more than two prior systemic treatments and no more than one prior radiotherapy treatment (preconditioning and transplantation for hematopoietic stem cells are counted as one systemic treatment; radiotherapy, regardless of fractionation or dose, including concurrent chemoradiotherapy, is counted as one treatment).
• Patients with measurable lesions identified by gadolinium-enhanced brain MRI (CT may be used if MRI is contraindicated).
• Patients with an ECOG Performance Status (PS) score of 2 or less.
• Patients who agree to comply with the Pregnancy Prevention Plan (PPP) for lenalidomide.
• Patients with an expected survival of at least 3 months, as judged by the investigator.

You may not qualify if:

• Patients newly diagnosed with primary central nervous system lymphoma (PCNSL).
• Patients with ocular lymphoma without brain lesions.
• Patients with metastatic CNS lymphoma involving organs outside the central nervous system, except th eeyes and cerebrospinal fluid (if systemic disease is present: Secondary CNS lymphoma).
• Patients whose screening laboratory test results meet the following criteria (⁕ corrected after transfusion or use of hematopoietic growth factors are acceptable):
• (1) Absolute neutrophil count \<1,000/μL (at least 2 weeks after G-CSF administration).
• (2) Platelet count \<75,000/μL (at least 1 week after platelet transfusion). (3) Hemoglobin \<9.0 g/dL (at least 2 weeks after red blood cell transfusion). (4) Serum calcium \>12.0 mg/dL. (5) Serum creatinine \>1.5 x the upper normal limit (UNL) or creatinine clearance \<60 mL/min (based on the Cockcroft-Gault formula).
• (6) Alanine aminotransferase (ALT) \>3 × UNL. (7) Aspartate aminotransferase (AST) \>3 × UNL. (8) Total bilirubin \>1.5 × UNL (Gilbert syndrome: up to 3 × UNL).
• Patients with cardiovascular, hepatic, renal, neurological, immune, infectious, or psychiatric disorders that could affect safety, trial evaluation, or protocol compliance (e.g., regular visits).
• \. The following heart conditions:
• Symptomatic or uncontrolled angina and congestive heart failure.
• Arrhythmias requiring medication (controlled cases with medication are allowed).
• Clinically significant myocardial infarction within 6 months before trial participation.
• \. History of thrombosis or embolism within 6 months before screening.
• \. Gastrointestinal bleeding above Grade 2 according to CTCAE within 6 months before screening.
• \. Ongoing infection above Grade 2 according to CTCAE at the time of screening.

Sponsors & Collaborators

• NOBO Medicine: lead

Study Sites (10)

Kosin University Gospel Hospital

Busan, South Korea

NOT YET RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, South Korea

NOT YET RECRUITING

Korea National Cancer Center

Ilsan, South Korea

NOT YET RECRUITING

Seoul National University Bundang Hospital

Seongnam, South Korea

NOT YET RECRUITING

Asan Medical Center

Seoul, South Korea

NOT YET RECRUITING

Catholic univ of Yeouido St Mary's Hospital

Seoul, South Korea

NOT YET RECRUITING

Korea University Anam Hospital

Seoul, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hong Yul An, Dr

  NOBO Medicine

  STUDY DIRECTOR

Central Study Contacts

Hong Yul An

CONTACT

02-6215-6200; anhongyul@nobomedicine.com

Sukyung Je

CONTACT

82-2-6215-6200; sukyung.je@nobomedicine.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This clinical study is conducted as an open, single-arm study targeting a patient population with rare diseases for which there is no distinct standard of care treatment.

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 17, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

KR (10)