Innovative 3D Preclinical Models for Mature B-cell Malignancies to Advance Personalized Immuno and Combination Therapies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- To generate 3D culture models from patients with CLL, SMZL, HCL
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CLL
Patients diagnosed with CLL
HCL
Patients diagnosed with HCL
SMZL
Patients diagnosed with SMZL
Outcomes
Primary Outcomes
To generate 3D culture models from patients with CLL, SMZL, HCL
Time Frame: 36 months
≥50% 3D culture models generated from patients with CLL, SMZL and HCL, defined as cell viability \>80% per sample in standard condition
Secondary Outcomes
No secondary outcomes reported
Investigators
Cristina Scielzo
Head, Malignant B cells biology and 3D modelling Unit
IRCCS San Raffaele