Using liquid biopsy to diagnose and monitor brain involvement in high-risk B-cell lymphoma
LIBERTY: Liquid Biopsy to Diagnose and Monitor Central Nervous System (CNS) Involvement in High-risk B Cell Non-Hodgkin Lymphoma
NA · Swiss Group for Clinical Cancer Research · NCT06090162
This study is testing if a new method using blood samples can help doctors better diagnose and track brain involvement in patients with high-risk B-cell lymphoma.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Swiss Group for Clinical Cancer Research (other) |
| Locations | 13 sites (Aarau and 12 other locations) |
| Trial ID | NCT06090162 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of circulating tumor DNA (ctDNA) detected in cerebrospinal fluid (CSF) to improve the diagnosis and monitoring of central nervous system (CNS) involvement in patients with high-risk B-cell non-Hodgkin lymphoma (B-NHL). The researchers aim to enhance risk stratification at diagnosis and evaluate treatment responses through ctDNA analysis. By identifying patients at high risk for CNS relapse, the study seeks to guide therapeutic management and potentially improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with newly diagnosed high-risk B-cell non-Hodgkin lymphoma exhibiting specific clinical characteristics.
Not a fit: Patients with low-risk B-cell non-Hodgkin lymphoma or those without CNS involvement may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of CNS involvement and more tailored treatment strategies for patients with aggressive B-NHL.
How similar studies have performed: Other studies have shown promising results using ctDNA for monitoring and diagnosis in various cancers, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aarau and 12 other locations
- Kantonspital Aarau — Aarau, Switzerland (NOT_YET_RECRUITING)
- Universitätsspital Basel — Basel, Switzerland (RECRUITING)
- Istituto Oncologico della Svizzera Italiana (IOSI) — Bellinzona, Switzerland (NOT_YET_RECRUITING)
- Inselspital Bern - Universitätsklinik für Medizinische Onkologie — Bern, Switzerland (RECRUITING)
- Kantonsspital Graubünden — Chur, Switzerland (RECRUITING)
- Hôpital Fribourgeois - Hôpital Cantonal — Fribourg, Switzerland (RECRUITING)
- Hopitaux Universitaire de Genève (HUG) — Geneva, Switzerland (RECRUITING)
- CHUV - Départment d'oncologie — Lausanne, Switzerland (NOT_YET_RECRUITING)
- Kantonsspital Baselland — Liestal, Switzerland (RECRUITING)
- Hôpital du Valais, Hôpital de Sion — Sion, Switzerland (RECRUITING)
- Kantonsspital St. Gallen — St. Gallen, Switzerland (RECRUITING)
- Klinik für Hämatologie und Onkologie Hirslanden Zürich — Zurich, Switzerland (RECRUITING)
- Stadtspital Triemli Zürich — Zürich, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Sabrina Chiquet
- Email: trials@sakk.ch
- Phone: +41 31 389 91 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-hodgkin Lymphoma, B Cell, High-risk B Cell Non-Hodgkin Lymphoma, ctDNA, experimental diagnostic test