Status:
RECRUITING
LIBERTY: Liquid Biopsy to Diagnose and Monitor CNS Involvement in High-risk B Cell Non-Hodgkin Lymphoma
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Non-hodgkin Lymphoma, B Cell
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prevention and treatment of CNS relapse remains a great unmet clinical need in the management of aggressive B-NHL. Hence, investigating novel diagnostic tests is of paramount importance to improve ris...
Detailed Description
Non-Hodgkin B-cell lymphoma (B-NHL) are cancers that arise from a subtype of white blood cells (lymphocyte) and typically involve the lymphatic system; they represent 4% of all cancers \[SEER database...
Eligibility Criteria
Inclusion
- Informed consent as documented by signature before registration and prior to any trial specific procedures, according to Swiss law and ICH E6 regulations Swiss law and ICH GCP E6(R2) regulations before registration.
- Histologically and/or cytologically confirmed newly diagnosed lymphomas including the following:
- Diffuse large B-cell lymphoma (DLBCL) with at least one of the following characteristics:
- CNS IPI \> 4
- Non-GC/ABC subtype with IPI \> 3
- Testicular involvement
- Breast involvement
- Kidney involvement
- Adrenal involvement
- Paranasal sinus / orbit involvement
- Involvement of ≥ 3 extranodal sites
- HIV-positive
- Radiological or histological CNS involvement
- High-grade B-cell lymphoma with MYC translocation with BCL2 and / or BCL6 (HGBL)
- Burkitt lymphoma
- Mantle cell lymphoma (blastoid variant or Ki67 \>30% or TP53 mutated)
- Primary CNS lymphoma
- Note:
- Aggressive transformation from indolent lymphomas (pretreated or not) are allowed
- Patients enrolled in other clinical trials may be included
- Patients must be willing to undergo a lumbar puncture at screening
- Age ≥ 18 years
Exclusion
- Subtypes of Non-Hodgkin lymphoma (NHL) not fulfilling above mentioned criteria (e.g., indolent lymphoma, T-cell lymphoma)
- Relapsing B-NHL
- Low/intermediate-risk DLBCL (CNS-IPI \< 4) AND no CNS involvement on imaging
- Any prior lymphoma-directed therapy before registration, with the exception of a maximum of 48 hours steroids prior to lumbar puncture procedure and therapies received for indolent lymphomas prior to transformation
- Any active advanced or metastatic cancer
- Any clinical contraindication to lumbar puncture procedure as per local guidelines
- Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned diagnostic procedure.
Key Trial Info
Start Date :
March 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06090162
Start Date
March 12 2024
End Date
December 1 2026
Last Update
October 2 2025
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Kantonspital Aarau
Aarau, Switzerland, 5001
2
Universitätsspital Basel
Basel, Switzerland, 4056
3
Istituto Oncologico della Svizzera Italiana (IOSI)
Bellinzona, Switzerland, 6500
4
Inselspital Bern - Universitätsklinik für Medizinische Onkologie
Bern, Switzerland, 3010