ClinicalTrials.gov record NCT07759661

Innovative 3D Preclinical Models for Mature B-cell Malignancies to Advance Personalized Immuno and Combination Therapies

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Age18 years old and older

SexAll

LocationItaly

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study enrolls adults with CLL, SMZL, or HCL. Participants give extra blood during routine blood draws; researchers will create and study 3D bioprinted models that mimic lymphoid tissue. The work aims to develop laboratory models that remain viable and reproduce disease microenvironments for research.

What it is studying. Whether patient-derived 3D bioprinted culture models can be generated from participants' blood and kept viable to reproduce key lymphoid tissue environments for laboratory study.

What the researchers hope to learn. Develop and validate patient-derived 3D bioprinted models that reproduce key lymphoid microenvironments. Primary outcome: generate ≥50% 3D culture models from patients with CLL, SMZL, and HCL, defined as cell viability >80% per sample in standard condition within 36 months.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Adult patients with chronic lymphocytic leukemia (CLL), splenic marginal-zone lymphoma (SMZL) and hairy cell leukemia (HCL) followed at participating clinical sites will be enrolled and undergo sampling of additional amount of blood during the blood draws performed as part of standard clinical care. The project aims to develop and validate innovative patient-derived 3D bioprinted models that faithfully reproduce the key microenvironments of lymphoid tissues, enabling a more physiologically relevant study of mature B-cell malignancies.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

Age ≥18 years
Diagnosis of CLL, SMZL or HCL
Participant is willing and able to autonomously give informed consent for participation in the study.

Exclusion criteria

Participant is unable or unwilling to provide informed consent for participation in the study

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will be asked to give informed consent and to provide extra blood during the blood draws that are already part of their routine clinical care. The additional blood samples will be used in the laboratory to create and test patient-derived 3D bioprinted models that reproduce lymphoid tissue environments. The study's primary outcome is to generate these 3D culture models, with work and sample use planned over a 36‑month timeframe.

How the study is structured. Prospective observational cohort study with three groups (CLL, SMZL, HCL). Participants provide additional blood during standard clinical blood draws. Samples are used to create and evaluate 3D culture models over the study period; no experimental treatment is given.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The registry says recruitment has not started. When is it expected to open, and can I register interest now?
The listed sites are in Italy. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on splenic marginal zone lymphoma

Clinical trials12 trials listed for splenic marginal zone lymphomaEvery trial the registry lists for splenic marginal zone lymphoma, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in splenic marginal zone lymphoma researchLatest monthly update: July 2026. Includes: Slow disease course. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: November 2026 (estimated)
Primary completion: November 2029 (estimated)
Study completion: November 2029 (estimated)
Target enrollment: 64 participants (estimated)
Last updated on registry: Aug 13, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: IRCCS San Raffaele
Principal investigator: Cristina Scielzo, Head, Malignant B cells biology and 3D modelling Unit
IRCCS San Raffaele
Collaborators: Ministry of Health, Italy

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Cristina Scielzo, PhD 📞 +390226436487 ✉ scielzo.cristina@hsr.it
Lydia Scarfò, MD 📞 +390226436119 ✉ scarfo.lydia@hsr.it

Participating sites (1)

IRCCS Ospedale San Raffaele
Milan, MI, 20132 · Italy
- Cristina Scielzo, PhD · +390226436487 · scielzo.cristina@hsr.it
- Lydia Scarfò, MD · +390226436119 · scarfo.lydia@hsr.it

Terms used on this page · explanations by MedicalUpdates.ai

informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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