LIBERTY: Liquid Biopsy to Diagnose and Monitor CNS Involvement in High-risk B Cell Non-Hodgkin Ly… (NCT06090162) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
LIBERTY: Liquid Biopsy to Diagnose and Monitor CNS Involvement in High-risk B Cell Non-Hodgkin Lymphoma
Switzerland64 participantsStarted 2024-03-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 maxim…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.