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NCT Number: NCT07759661

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

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia (CLL) Chronic Disease Disease Attributes Hairy Cell Leukemia (HCL) Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Hairy Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Splenic Marginal Zone Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 36 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina Scielzo, PhD

CONTACT

[email protected]

+390226436487

Lydia Scarfò, MD

CONTACT

[email protected]

+390226436119

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

  • Ministry of Health, Italy

Registry information

Acronym: IMPACT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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