Actively Recruiting
NB02 (Poseltinib) Combined Rituximab and Lenalidomide in R/R PCNSL
Led by NOBO Medicine · Updated on 2024-12-17
33
Participants Needed
10
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
NB02 (Poseltinib) Combined Rituximab and Lenalidomide in R/R PCNSL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily consent to participate after being informed about the study and the investigational drug.
- Adults aged 19 to 80 years.
- Histopathologically diagnosed with CD20-positive primary central nervous system lymphoma.
- Experienced disease progression or resistance after remission induction, radiotherapy, or autologous transplantation, with no more than two prior systemic treatments and one prior radiotherapy treatment.
- Have measurable lesions confirmed by gadolinium-enhanced brain MRI or CT if MRI is contraindicated.
- Have an ECOG Performance Status score of 2 or less.
- Agree to follow the Pregnancy Prevention Plan for lenalidomide.
- Expected survival of at least 3 months as judged by the investigator.
You will not qualify if you...
- Newly diagnosed primary central nervous system lymphoma patients.
- Patients with ocular lymphoma without brain lesions.
- Patients with metastatic CNS lymphoma involving organs outside the CNS except eyes and cerebrospinal fluid.
- Specific abnormal lab test results: absolute neutrophil count <1,000/µL, platelet count <75,000/µL, hemoglobin <9.0 g/dL, serum calcium >12.0 mg/dL, serum creatinine >1.5x normal or creatinine clearance <60 mL/min, ALT or AST >3x normal, total bilirubin >1.5x normal (except Gilbert syndrome up to 3x).
- Patients with cardiovascular, hepatic, renal, neurological, immune, infectious, or psychiatric disorders affecting safety or compliance.
- Symptomatic or uncontrolled angina, congestive heart failure, recent significant myocardial infarction, or arrhythmias requiring medication.
- History of thrombosis or embolism within 6 months.
- Recent gastrointestinal bleeding or ongoing infection above Grade 2.
- Severe hepatic impairment or uncontrolled hepatitis B or C infections.
- HIV infection unless antibody-negative or antigen-negative despite positivity.
- Severe renal impairment requiring dialysis.
- Known immunodeficiency or autoimmune diseases.
- History of severe cutaneous adverse reactions.
- History of other malignancies unless disease-free or cured for 5 years under specified conditions.
- Suspected moderate dementia.
- Unable to take oral medication.
- Hypersensitivity to study drugs or excipients.
- Prior use of lenalidomide, poseltinib, or other BTK inhibitors.
- Genetic disorders like galactose intolerance or glucose-galactose malabsorption.
- Pregnant or breastfeeding women.
- Women or men not agreeing to specified contraceptive measures.
- History of substance abuse or conditions interfering with participation or compliance.
- Unable to understand or follow trial instructions or with poor prior treatment adherence.
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Kosin University Gospel Hospital
Busan, South Korea
Not Yet Recruiting
2
Chonnam National University Hwasun Hospital
Hwasun, South Korea
Not Yet Recruiting
3
Korea National Cancer Center
Ilsan, South Korea
Not Yet Recruiting
4
Seoul National University Bundang Hospital
Seongnam, South Korea
Not Yet Recruiting
5
Asan Medical Center
Seoul, South Korea
Not Yet Recruiting
6
Catholic univ of Yeouido St Mary's Hospital
Seoul, South Korea
Not Yet Recruiting
7
Korea University Anam Hospital
Seoul, South Korea
Not Yet Recruiting
8
Samsung Medical Center
Seoul, South Korea
Not Yet Recruiting
9
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
10
Ulsan University Hospital
Ulsan, South Korea
Not Yet Recruiting
Research Team
H
Hong Yul An
CONTACT
S
Sukyung Je
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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