Clinical trial · Interventional
Bruton's Tyrosine Kinase Inhibitor Ibrutinib as Maintenance Treatment in Elderly Patients With Primary CNS Lymphoma
Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib as Maintenance Treatment in Elderly Patients With Primary CNS Lymphoma Following First Line Chemotherapy Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study will include 30 elderly patients age 60-85 with primary CNS DLBCL . Induction treatment will include Rituximab and high dose methotrexate protocol (containing at least methotrexate and one more chemotherapy agent). Patients with MRI documented response CR or PR will enter the study protocol maintenance phase which will include continous treatment with Ibrutinib 560 mg day until relapse or disease progression or occurrence of limiting toxicities
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Lymphoma | Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imbruvica | Drug | Ibrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- Imbruvica (ibrutinib) will be given as maintenance treatment until relapse or toxicity to 30 elderly PCNSL patients after achieving response to first line treatment
- interventionNames
- Drug: Imbruvica
Primary outcomes (1)
- measure
- PFS- progression free survival
- timeFrame
- 3 years
- description
- Progression free survival
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- 4 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed PCNSL patients whose age is \>60 years and achieved response (CR/PR) after first line immunochemotherapy treatment * Tissue diagnosis is mandatory unless positive cerebrospinal fluid (CSF) cytology or vitrectomy are diagnostic with no evidence for systemic disease * No contraindication for high dose methotrexate (HD-MTX) (adequate renal function) * KPS \> 40%, ECOG \< 3 * Hematology values must be within the following limits: Absolute neutrophil count (ANC) ≥ 1000/µl independent of growth factor support Platelets ≥100,000/µl or ≥50,000/µl if bone marrow involvement independent of transfusion support in either situation • Biochemical values within the following limits: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) Total bilirubin ≤ 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin Serum creatinine ≤ 2 x ULN or estimated Glomerular Filtration Rate (Cockroft Gault≥ 40 mL/min \- Exclusion Criteria: * Major surgery within 4 weeks of randomization. * History of stroke or intracranial hemorrhage within 6 months prior to randomization. * Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon). * Requires treatment with strong CYP3A inhibitors. * Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification. * Vaccinated with live, attenuated vaccines within 4 weeks of randomization. * Known history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics. * Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
References
Publications (1)
- DERIVEDBairey O, Taliansky A, Glik A, Amiel A, Yust-Katz S, Gurion R, Zektser M, Porges T, Sarid N, Horowitz NA, Shina TT, Lebel E, Cohen A, Geiger KR, Raanani P, Wolach O, Siegal T. A phase 2 study of ibrutinib maintenance following first-line high-dose methotrexate-based chemotherapy for elderly patients with primary central nervous system lymphoma. Cancer. 2023 Dec 15;129(24):3905-3914. doi: 10.1002/cncr.34985. Epub 2023 Aug 12. PMID 37572086