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
Swiss Cancer Institute
64 participants
Mar 12, 2024
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria22
- 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 Criteria7
- 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.
Interventions
ctDNA detection on CSF and blood
Locations(14)
View Full Details on ClinicalTrials.gov
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NCT06090162