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New treatment option for Primary CNS Lymphoma (PCNSL)
Official title NB02 (Poseltinib) Combined Rituximab and Lenalidomide in R/R PCNSL
ClinicalTrials.gov ID: NCT06737250
What this study is testing
What is R2P -> RP?
R2P -> RP is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary cns lymphoma (pcnsl).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 80
You may be able to join if
- A patient who voluntarily decided to participate and provided written consent after receiving an explanation of this clinical trial and the...
- 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...
- Patients with measurable lesions identified by gadolinium-enhanced brain MRI (CT may be used if MRI is contraindicated).
You likely can't join 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...
- Patients whose screening laboratory test results meet the following criteria (⁕ corrected after transfusion or use of hematopoietic growth factors...
- Patients with cardiovascular, hepatic, renal, neurological, immune, infectious, or psychiatric disorders that could affect safety, trial evaluation...
- Symptomatic or uncontrolled angina and congestive heart failure.
See the full eligibility criteria
- 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...
- 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.
- 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 \ 12.0 mg/dL. (5) Serum...
- Patients with cardiovascular, hepatic, renal, neurological, immune, infectious, or psychiatric disorders that could affect safety, trial evaluation, or protocol compliance (e.g., regular visits). 5\. The following heart...
- 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. 6\. History of thrombosis or embolism within 6 months before screening. 7\. Gastrointestinal bleeding above Grade 2 according to...
- Patients with HBsAg (-) and HBcAb (-), or HBsAg (-) and HBcAb (+) with undetectable HBV DNA, can participate. Prophylactic antiviral therapy and HBV DNA monitoring (every 3-4 weeks) are required for HBcAb (+) cases with...
- Patients with negative HCV antibodies or undetectable HCV RNA can participate with HCV RNA monitoring (every 1 cycle). 11\. HIV infection. Patients with negative HIV antibodies or antigen-negative despite HIV antibody...
- No treatment for malignancy and disease-free for at least 5 years before screening.
- Completely cured with no evidence of recurrence for malignancies within 5 years if surgically treated (e.g., Stage I/II papillary or follicular thyroid cancer, basal cell/squamous cell carcinoma, cervical dysplasia or...
- Women not of childbearing potential include those who have undergone hysterectomy or bilateral oophorectomy, or those in natural menopause for at least 24 consecutive months for non-disease reasons. 24\. Male...
- Use condoms during the study, even after vasectomy, during temporary discontinuation, and for 12 months after the last administration.
- Avoid sperm/semen donation for 12 months after the study.
- Immediately inform investigators if their partner becomes pregnant during the study or within 3 months after the study. 25\. Patients with a history of substance abuse, medical, psychiatric, or social conditions that...
The study team makes the final eligibility decision.
Where it's taking place
- Busan, South Korea
- Hwasun, South Korea
- Ilsan, South Korea
- Seongnam, South Korea
- Seoul, South Korea
- Ulsan, South Korea
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Busan, South Korea; Hwasun, South Korea; Ilsan, South Korea; Seongnam, South Korea; Seoul, South Korea; Ulsan, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.