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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Splenic Marginal Zone Lymphoma; Chronic Lymphocytic Leukemia (CLL); Hairy Cell Leukemia (HCL)

• Study Type: Observational
• Enrollment (Estimated): 64

Contacts and Locations

• Study Contact: Name: Lydia Scarfò, MD; Phone Number: +390226436119; Email: scarfo.lydia@hsr.it
• Study Contact Backup: Name: Cristina Scielzo, PhD; Phone Number: +390226436487; Email: scielzo.cristina@hsr.it

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20132
      • IRCCS Ospedale San Raffaele
      • Contact: Lydia Scarfò, MD; Phone Number: +390226436119; Email: scarfo.lydia@hsr.it
      • Contact: Cristina Scielzo, PhD; Phone Number: +390226436487; Email: scielzo.cristina@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
CLL; Patients diagnosed with CLL
SMZL; Patients diagnosed with SMZL
HCL; Patients diagnosed with HCL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To generate 3D culture models from patients with CLL, SMZL, HCL	≥50% 3D culture models generated from patients with CLL, SMZL and HCL, defined as cell viability >80% per sample in standard condition	36 months

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Collaborators: Ministry of Health, Italy

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: August 7, 2026
• First Submitted That Met QC Criteria: August 7, 2026
• First Posted (Actual): August 12, 2026

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 11, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: B-cell malignancies; 3D models
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Hairy Cell
• Other Study ID Numbers: RF-2024-12377498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No