Clinical trial · Interventional
LIBERTY: Liquid Biopsy to Diagnose and Monitor CNS Involvement in High-risk B Cell Non-Hodgkin Lymphoma
LIBERTY: Liquid Biopsy to Diagnose and Monitor Central Nervous System (CNS) Involvement in High-risk B Cell Non-Hodgkin Lymphoma
- 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)
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 risk-stratification of lymphoma patients at diagnosis, as is the evaluation of novel therapeutic approaches that may prevent and / or treat CNS recurrence. Based on the highlighted evidence, the investigators hypothesize that ctDNA detected within the CSF could potentially improve the detection rate of CNS involvement and consequently improve patients' stratification and better discriminate those in need of consolidative CNS prophylaxis on a molecular basis. Similarly, the investigators postulate that CSF ctDNA could be used as a monitoring tool to assess treatment response and guide therapeutic management.
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 |
|---|---|---|---|
| Non-hodgkin Lymphoma, B Cell | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA detection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- experimental diagnostic test
- description
- Lumbar punction at diagnosis. CSF and blood samples will be assessed by the two diagnostic tests (CSF ctDNA and conventional test (CC/FC))
- interventionNames
- Diagnostic Test: ctDNA detection
Primary outcomes (1)
- measure
- Sensitivity
- timeFrame
- at baseline
- description
- Sensitivity of liquid biopsy (ctDNA) measured within CSF in its performance to detect CNS involvement in newly diagnosed high-risk B-NHL in comparison to standard conventional diagnostic approaches (CC / FC). For the evaluation of the primary endpoint, only patients with confirmed CNS involvement at baseline (real positives) will be analyzed. CNS involvement at baseline is defined as having at least one of the following conditions: * Positive brain or spine MRI * Neurological symptoms of lymphoma manifestations (including ophthalmic symptoms) * Histologically confirmed CNS involvement
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available