Primary CNS Lymphoma (PCNSL)Phase 2POTENTIAL-PNCT06737250
NB02 (Poseltinib) Combined Rituximab and Lenalidomide in R/R PCNSL
A Phase 2 study testing R2P -> RP in people with Primary CNS Lymphoma (PCNSL), run by NOBO Medicine at 10 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Primary CNS Lymphoma (PCNSL)
- What is being tested?
- R2P -> RP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 25 Nov 2024to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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):
- Absolute neutrophil count <1,000/μL (at least 2 weeks after G-CSF administration).
- 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).
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- 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).
- 5. 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.
- 6. History of thrombosis or embolism within 6 months before screening.
- 7. Gastrointestinal bleeding above Grade 2 according to CTCAE within 6 months before screening.
- 8. Ongoing infection above Grade 2 according to CTCAE at the time of screening.
- 9. Severe hepatic impairment (e.g., cirrhosis), chronic hepatitis with HBV reactivation.
- 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 undetectable HBV DNA.
- 10. Uncontrolled hepatitis C virus (HCV) infection.
- 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 positivity can participate.
- 12. Severe renal impairment requiring hemodialysis or hemofiltration at screening.
- 13. Known immunodeficiency disorders.
- 14. Known autoimmune diseases (e.g., multiple sclerosis, acute disseminated encephalomyelitis, rheumatoid arthritis).
- 15. History of severe cutaneous adverse reactions (SCARs), including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), or acute generalized exanthematous pustulosis (AGEP).
- 16. History of malignancies other than the target disease, except:
- 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 carcinoma in situ, early-stage stomach or colorectal cancer).
- 17. Patients suspected of moderate dementia (K-MMSE-2 score ≤17).
- 18. Patients unable to take oral medication.
- 19. Hypersensitivity to study drugs (rituximab, lenalidomide, poseltinib) or excipients.
- 20. Prior use of lenalidomide, poseltinib, or other BTK inhibitors.
- 21. Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- 22. Women who are pregnant or breastfeeding.
- 23. Women of childbearing potential⁕ and male participants with female partners of childbearing potential who do not agree to use two reliable contraceptive methods at least 28 days before administration of the investigational drug, during the trial, during temporary discontinuation, and for 12 months after the last administration. (Complete abstinence from heterosexual intercourse is an exception.)
- 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 participants who do not agree to:
- 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 could interfere with trial participation or results.
- 26. Patients unable to understand or comply with trial instructions or with a history of poor adherence to medical treatments.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
South Korea10 sites, 10 recruiting
- Not yet recruiting
Kosin University Gospel Hospital
Busan
Ho Sup Lee, 82-51-990-5820, hs3667@hanmail.net
- Not yet recruiting
Chonnam National University Hwasun Hospital
Hwasun
Deok-Hwan Yang, 82-61-379-7636, drydh1685@hotmail.com
- Not yet recruiting
Korea National Cancer Center
Ilsan
Hyeon-Seok Eom, 82-31-920-1505, ccpharm-ct@ncc.re.kr
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam
Jeong-Ok Lee, 82-31-787-7055, deafkeller@snubh.org
- Not yet recruiting
Asan Medical Center
Seoul
Dok Hyun Yoon, 82-2-3010-6961, dhyoon@amc.seoul.kr
- Not yet recruiting
Catholic univ of Yeouido St Mary's Hospital
Seoul
Young Woo Jeon, 82-2-3779-1049, native47@catholic.ac.kr
- Not yet recruiting
Korea University Anam Hospital
Seoul
Yoon Seok Choi, 82-2-787-7055, wyfran@gmail.com
- Not yet recruiting
Samsung Medical Center
Seoul
Won Seog Kim, 82-2-2148-7390, wonseog.kim@samsung.com
- Recruiting
Seoul National University Hospital
Seoul
Jamin Byun, 82-2-2072-4850, jaminbyun@snu.ac.kr
- Not yet recruiting
Ulsan University Hospital
Ulsan
Jae Cheol Jo, 82-52-250-7048, jcjo@uuh.ulsan.kr
About this study
Official title: 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
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
Read the 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)
- Being tested
- R2P -> RP
- Keywords
- Refractory, Relapsed
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R2P -> RPDrug
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
| Study group | Role | What they receive |
|---|---|---|
| NB02 (Poseltinib) combined Rituximab and Lenalidomide | Experimental | Not described Receives: Drug: R2P -> RP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response (ORR) by IRC
End Of Induction
Measured: 4 cycles (12 weeks)
Secondary outcomes (6)
Overall Response by Investigator (ORR)
End Of Induction
Measured: 4 cycles (12 weeks)
Overall Survival (OS)
End of Study
Measured: through study completion, an estimation of 2 years
Progression Free Survival (PFS)
End Of Treatment
Measured: through study completion, an estimation of 2 years
Event Free Survival (EFS)
End Of Study
Measured: through study completion, an estimation of 2 years
Response Duration
End Of Treatment
Measured: through study completion, an estimation of 2 years
Time To Response
End Of Treatment
Measured: through study completion, an estimation of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start25 Nov 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary CNS Lymphoma (PCNSL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NOBO Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong Yul An, Dr, Study director, NOBO Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737250
- Sponsor's protocol ID
- 20240084640
- Acronym
- POTENTIAL-P
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06737250
- Acronym / sponsor ID
- POTENTIAL-P / 20240084640
- Conditions
- Primary CNS Lymphoma (PCNSL)
- Keywords
- Refractory, Relapsed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- NOBO MedicineIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| NB02 (Poseltinib) combined Rituximab and Lenalidomide | Experimental | Drug: R2P -> RP |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (41 listed)
- 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):
- Absolute neutrophil count <1,000/μL (at least 2 weeks after G-CSF administration).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R2P -> RPInduction(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 | Drug | NB02 (Poseltinib) combined Rituximab and Lenalidomide |
Primary outcome
Overall Response (ORR) by IRC
Time frame: 4 cycles (12 weeks)
End Of Induction
6 secondary outcomes
Overall Response by Investigator (ORR)
Time frame: 4 cycles (12 weeks)
Overall Survival (OS)
Time frame: through study completion, an estimation of 2 years
Progression Free Survival (PFS)
Time frame: through study completion, an estimation of 2 years
Event Free Survival (EFS)
Time frame: through study completion, an estimation of 2 years
Response Duration
Time frame: through study completion, an estimation of 2 years
Time To Response
Time frame: through study completion, an estimation of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hong Yul An, Dr study director
NOBO Medicine
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R2P -> RP in people with Primary CNS Lymphoma (PCNSL), run by NOBO Medicine at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Yul An (02-6215-6200, anhongyul@nobomedicine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response (ORR) by IRC (time frame: 4 cycles (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.