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

NCT07759661 | Not Yet Recruiting

• 1 other identifier: RF-2024-12377498
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Lymphocytic Leukemia (CLL); Splenic Marginal Zone Lymphoma; Hairy Cell Leukemia (HCL)

Keywords

B-cell malignancies; 3D models

Outcome Measures

Primary Outcomes (1)

• To generate 3D culture models from patients with CLL, SMZL, HCL

  To generate 3D culture models from patients with CLL, SMZL, HCL

  36 months

Study Arms (3)

CLL

Patients diagnosed with CLL

SMZL

Patients diagnosed with SMZL

HCL

Patients diagnosed with HCL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with CLL, SMZL, HCL followed at participating clinical sites

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Ministry of Health, Italy: collaborator

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Hairy Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cristina Scielzo, PhD

CONTACT

+390226436487; scielzo.cristina@hsr.it

Lydia Scarfò, MD

CONTACT

+390226436119; scarfo.lydia@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)