Chronic Lymphocytic Leukemia (CLL)IMPACTNCT07759661
Innovative 3D Preclinical Models for Mature B-cell Malignancies to Advance Personalized Immuno and Combination Therapies
An observational study of Chronic Lymphocytic Leukemia (CLL) and Splenic Marginal Zone Lymphoma, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia (CLL), Splenic Marginal Zone Lymphoma, Hairy Cell Leukemia (HCL)
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2026to Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with CLL, SMZL, HCL followed at participating clinical sites
Who may be able to join
- Age ≥18 years
- Diagnosis of CLL, SMZL or HCL
- Participant is willing and able to autonomously give informed consent for participation in the study.
Who cannot join
- Participant is unable or unwilling to provide informed consent for participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Ospedale San Raffaele
Milan, MI, 20132
Cristina Scielzo, PhD, +390226436487, scielzo.cristina@hsr.it
Lydia Scarfò, MD, +390226436119, scarfo.lydia@hsr.it
About this study
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
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Hairy Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CLL | Patients diagnosed with CLL | |
| SMZL | Patients diagnosed with SMZL | |
| HCL | Patients diagnosed with HCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia (CLL)Studies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Principal investigator, Cristina Scielzo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759661
- Sponsor's protocol ID
- RF-2024-12377498
- Acronym
- IMPACT
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative 3D Preclinical Models for Mature B-cell Malignancies to Advance Personalized Immuno and Combination Therapies
- ClinicalTrials.gov ID
- NCT07759661
- Acronym / sponsor ID
- IMPACT / RF-2024-12377498
- Conditions
- Chronic Lymphocytic Leukemia (CLL), Splenic Marginal Zone Lymphoma, Hairy Cell Leukemia (HCL)
- Keywords
- B-cell malignancies, 3D models
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CLL | – | –Patients diagnosed with CLL |
| SMZL | – | –Patients diagnosed with SMZL |
| HCL | – | –Patients diagnosed with HCL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with CLL, SMZL, HCL followed at participating clinical sites
Key inclusion criteria (3 listed)
- Age ≥18 years
- Diagnosis of CLL, SMZL or HCL
- Participant is willing and able to autonomously give informed consent for participation in the study.
Key exclusion criteria (1 listed)
- Participant is unable or unwilling to provide informed consent for participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia (CLL) and Splenic Marginal Zone Lymphoma, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Scielzo, PhD (+390226436487, scielzo.cristina@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To generate 3D culture models from patients with CLL, SMZL, HCL (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.