Clinical trial Recruiting at 1 site Observational Ages 18 and up

LEF1 levels as a diagnostic and survival marker in CLL/SLL

Official title: RILEVANZA DIAGNOSTICA DELLA ESPRESSIONE DI LEF-1 NEL LINFOMA A PICCOLI LINFOCITI/LEUCEMIA LINFATICA CRONICA B

Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07313982 · Data updated 2026-11-12

We will test whether measuring LEF1 protein in lymph node, bone marrow, or other tissue samples can help diagnose and predict outcomes for adults with CLL/SLL.

More Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment350 (estimated)
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Academic / other
Locations1 site (Bologna, BOLOGNA)
StatusRecruiting
StartedDecember 31, 2025
Main results expectedFebruary 28, 2026
Study endsAugust 31, 2027
Registry record updatedJanuary 2, 2026
Trial IDNCT07313982 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with a confirmed diagnosis of CLL/SLL who have available lymph node, extranodal, or bone marrow tissue and submitted mutational and/or cytogenetic analysis data are ideal candidates.

Probably not a fit

Patients without an available biopsy/tissue sample or those whose diagnosis is not genetically supported as CLL/SLL are unlikely to benefit from this analysis.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study measures LEF1 expression by immunohistochemistry on available lymph node, extranodal, or bone marrow tissue from adults with confirmed CLL/SLL and links those results to existing mutational and cytogenetic data. Investigators will correlate LEF1 levels with diagnostic features, genetic risk markers, and clinical outcomes including survival. The work uses existing patient samples and data collected at a single tertiary center in Bologna, Italy. No investigational treatments are administered as part of this protocol.

Why it matters

Potential benefit: If successful, LEF1 testing could help doctors identify patients at higher risk and refine prognostic stratification to guide monitoring and treatment decisions.

How similar studies have gone: Previous research has reported LEF1 overexpression and Wnt pathway activation in CLL, so this work builds on existing findings rather than introducing an entirely novel marker.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients with a confirmed diagnosis of SLL/CLL - B
* Males and females, adults at diagnosis
* Patients with available tissue (lymph node, extralymph node, or bone marrow) on which immunohistochemical analysis including LEF-1 has been performed and who have already submitted mutational and/or cytogenetic analysis data.

Exclusion Criteria:

* \- Patients with LEF1-positive indolent B-cell lymphomas not supported by a genetic evaluation with SSL/CLL.
* CLL cases for which a biopsy is not available

Where it's running

  • Irccs Azienda Ospedaliero-Universitaria Di Bologna
    Bologna, Bologna, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Using venetoclax to treat CLL patients on BTK inhibitors

    This study is testing if adding venetoclax to the treatment of chronic lymphocytic leukemia (CLL) patients already on BTK inhibitors can help improve their condition after six months of treatment.

    Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT06958705

  • Rocbrutinib and Lacutoclax in B-cell cancers

    This study tests whether Rocbrutinib plus Lacutoclax can help adults with B-cell malignancies, including CLL/SLL, MCL, DLBCL, FL, WM, who have had prior therapy or are treatment-naïve under specific criteria.

    Recruiting Phase 1/2 Guangzhou Lupeng Pharmaceutical Company LTD. · Tianjin · NCT07609862

  • Testing EXS73565 for patients with relapsed or refractory B-cell cancers

    This study is testing a new oral medication called EXS73565 to see if it can help adults with B-cell cancers that haven't responded to other treatments.

    Recruiting at 17 sites Phase 1 Exscientia AI Limited · Tbilisi and 16 other locations · NCT06980116

  • Evaluating CTX112 for B-cell malignancies

    This study is testing a new type of CAR T cell therapy called CTX112 to see if it can safely help people with tough-to-treat B-cell cancers.

    Recruiting at 7 sites Phase 1/2 CRISPR Therapeutics · Westwood, Kansas and 6 other locations · NCT05643742

  • APG-3288 in relapsed/refractory blood cancers

    This study tests APG-3288 alone to see if it can be safely given and what dose works best in people whose blood cancers have returned or stopped responding to standard treatments.

    Recruiting at 5 sites Phase 1 Ascentage Pharma Group Inc. · Los Angeles, California and 5 other locations · NCT07424833

  • Pirtobrutinib for Elderly CLL: See if this BTK inhibitor helps older adults

    This study tests whether pirtobrutinib can help people aged 75 and older with chronic lymphocytic leukemia that hasn’t been treated yet.

    Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07685717

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.