Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Italy / NCT05782374
Active, not recruiting Observational

Real World Data on Ibrutinib Use in PCNSL Rel/Ref

NCT05782374 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Observational
Started
2022-08-10
Last updated
2026-02-03

Condition(s) studied

PCNSL

Investigational drug(s) / intervention(s)

Ibrutinib →

Ibrutinib: ibrutinib alone or in combination with R-CHOP or R-CHOP like

Study summary

PCNSL is a rare and aggressive subtype of B lymphoma that has been recognized as a distinct disease entity in the latest edition of the WHO Classification of Tumors of Haematopoietic and Lymphoid Tissue and is defined as DLBCL that develops exclusively in the brain parenchyma, spinal cord, leptomeninges and eye. In patients under 70 years of age without severe comorbidities, first-line treatment with induction chemo-immunotherapy according to the MATRix scheme (Methotrexate, Cytarabine, Tiothepa, Rituximab) and subsequent consolidation with HDCT followed by ASCT achieved the best results in terms of PFS and OS. Data on patients enrolled in a randomized phase 2 study showed an OS of 70% at a median FU of 88 months. In patients\> 70 years of age or with low KPS, the prognosis remains significantly lower in the younger population. Several population studies have shown a stable increase over the past 30 years in terms of PFS and OS in patients aged under 70 years, while in patients over 70 years or with KPS \<70%, the survival curves are not satisfactory. in part because these patients are often referred to BSC alone, despite the benefit in PFS and OS demonstrated with HD-MTX-based treatments (≥1 g / m2) combined with oral alkylating agents or cytarabine in high doses.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Histological or cytological diagnosis of DLBCL * Disease localized exclusively in the CNS (brain, meninges, cranial nerves, eyes and / or spinal cord) both at first diagnosis and at failure * Progressive or recurrent disease * Previous treatment with high-dose methotrexate-based chemotherapy ± WBRT * Age 18 - 80 years * ECOG performance status 0-3 * Adequate hematopoiesis (platelets\> 25,000 / mm3, hemoglobin\> 8 g / dL, ANC\> 1,000 / mm3), renal (serum creatinine \<2 times UNL and creatinine clearance ≥40 mL / min), cardiac (VEF ≥50% ) and liver function (SGOT / SGPT \<3 times UNL, bilirubin and alkaline phosphatase \<2 times UNL). * Patients who have been given treatment with ibrutinib, alone or in combination with immunochemotherapy, and who have or have not received the same. Exclusion Criteria: * Patients with concomitant extra-CNS disease at presentation or relapse * Symptomatic coronary heart disease, cardiac arrhythmias not well controlled with drugs, or myocardial infarction within the past 6 months (New York Heart Association class III or IV heart disease) * Any other serious medical condition that could compromise the patient's ability to adhere to treatment. * Presence of any psychological, family, sociological or geographical condition that may hinder compliance with the study protocol and the follow-up program. * In therapy with strong CYP3A inhibitors

Primary outcome measure(s)

  • To evaluate the efficacy in terms of overall rate of responses in patients treatment — 6MONTH
    To evaluate the efficacy in terms of overall rate of responses to treatment (ORR = sum of complete responses \[CR\] + partial responses \[PR\]) according to the IPCG 2005 criteria in a retrospective cohort of patients with relapsed / refractory PCNSL undergoing treatment with ibrutinib given as monotherapy or in combination with R-CHOP immuno-chemotherapy.

Trial sites (1)

FacilityCityRegionStatus
Ospedale San Raffaele Milan Italy

On this site

📄 Imbruvica (ibrutinib) drug profile →

More IRCCS San Raffaele trials in Italy

Patient Reported Outcome Measurements (PROMs) Impact on Clinical Outcome in firsT Line settIng Non- Small-Cell Lung Cancer (NSCLC) According to Chemo- Immunotherapy reGimen Recruiting
Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma. Recruiting
Medically Assisted Fertilization Techniques in Systemic Immunoreumatologic Diseases Recruiting
Development of Novel Imaging and Molecular Biomarkers of Fibrosis in Patient With Ulcerative Colitis Recruiting
Next-Generation Endometriosis Diagnostics Through Comprehensive Multi-Dimensional Analysis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05782374 on ClinicalTrials.gov ↗ ← All trials in Italy