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

December 11, 2024 updated by: NOBO Medicine

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Not yet recruiting
        • Kosin University Gospel Hospital
        • Contact:
      • Hwasun, Korea, Republic of
        • Not yet recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
      • Ilsan, Korea, Republic of
        • Not yet recruiting
        • Korea National Cancer Center
        • Contact:
      • Seongnam, Korea, Republic of
        • Not yet recruiting
        • Seoul National University Bundang Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Asan Medical Center
        • Contact:
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Samsung Medical Center
        • Contact:
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Korea University Anam Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Catholic univ of Yeouido St Mary's Hospital
        • Contact:
      • Ulsan, Korea, Republic of
        • Not yet recruiting
        • Ulsan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Adults aged 19 years or older and 80 years or younger.
  3. Patients diagnosed histopathologically with CD20-positive primary central nervous system lymphoma (PCNSL).
  4. 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).
  5. Patients with measurable lesions identified by gadolinium-enhanced brain MRI (CT may be used if MRI is contraindicated).
  6. Patients with an ECOG Performance Status (PS) score of 2 or less.
  7. Patients who agree to comply with the Pregnancy Prevention Plan (PPP) for lenalidomide.
  8. Patients with an expected survival of at least 3 months, as judged by the investigator.

Exclusion Criteria:

  1. Patients newly diagnosed with primary central nervous system lymphoma (PCNSL).
  2. Patients with ocular lymphoma without brain lesions.
  3. 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).
  4. 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).

    5. The following heart conditions:

    1. Symptomatic or uncontrolled angina and congestive heart failure.
    2. Arrhythmias requiring medication (controlled cases with medication are allowed).
    3. 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:

      1. No treatment for malignancy and disease-free for at least 5 years before screening.
      2. 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:

    1. Use condoms during the study, even after vasectomy, during temporary discontinuation, and for 12 months after the last administration.
    2. Avoid sperm/semen donation for 12 months after the study.
    3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NB02 (Poseltinib) combined Rituximab and Lenalidomide
Drug: R2P -> 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response (ORR) by IRC
Time Frame: 4 cycles (12 weeks)
End Of Induction
4 cycles (12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response by Investigator (ORR)
Time Frame: 4 cycles (12 weeks)
End Of Induction
4 cycles (12 weeks)
Overall Survival (OS)
Time Frame: through study completion, an estimation of 2 years
End of Study
through study completion, an estimation of 2 years
Progression Free Survival (PFS)
Time Frame: through study completion, an estimation of 2 years
End Of Treatment
through study completion, an estimation of 2 years
Event Free Survival (EFS)
Time Frame: through study completion, an estimation of 2 years
End Of Study
through study completion, an estimation of 2 years
Response Duration
Time Frame: through study completion, an estimation of 2 years
End Of Treatment
through study completion, an estimation of 2 years
Time To Response
Time Frame: through study completion, an estimation of 2 years
End Of Treatment
through study completion, an estimation of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NOBO Medicine

Investigators

  • Study Director: Hong Yul An, Dr, NOBO Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20240084640

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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