Chronic Lymphocytic Leukemia (CLL)PS-CLL016NCT07741695
Targeting IRAK4 in Chronic Lymphocytic Leukemia
An observational study of Chronic Lymphocytic Leukemia (CLL), run by IRCCS San Raffaele.
Trial summary
Patients with chronic lymphocytic leukemia (CLL) followed at Strategic Research Program on CLL will be enrolled and undergo sampling of additional amount of blood at the time of standard blood tests. Leukemic B cells and peripheral blood mononuclear cells (PBMC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia (CLL)
- What is being tested?
- Peripheral blood sample collection
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2027
- 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 followed at Strategic Research Program on CLL
Who may be able to join
- Age ≥18 years
- Diagnosis of CLL
- Participant is willing and able to 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Patients with chronic lymphocytic leukemia (CLL) followed at Strategic Research Program on CLL will be enrolled and undergo sampling of additional amount of blood at the time of standard blood tests. Leukemic B cells and peripheral blood mononuclear cells (PBMC).
Read the detailed description
Patients with chronic lymphocytic leukemia (CLL) followed at Strategic Research Program on CLL will be enrolled and undergo sampling of additional amount of blood at the time of standard blood tests. Leukemic B cells and peripheral blood mononuclear cells (PBMC). Up to 50 ml of blood will be collected for the research project at the time of standard blood tests.
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Being tested
- Peripheral blood sample collection
- Keywords
- chronic lymphocytic leukemia, IRAK4
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood sample collectionProcedure or surgery
Up to 50 ml of blood will be collected for the research project at the time of standard blood tests.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Collection of peripheral blood (up to 50 ml) for the analysis of the biological activity of IRAK4 Chimeric Degradation Activation Compound (CDAC) in purified CLL B cells, assessed by changes in proliferation, apoptosis, and signaling pathway activation following in vitro treatment. Receives: Procedure: Peripheral blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
TLR signaling
In vitro inhibition of TLR signaling in CLL cells following exposure to IRAK4 CDAC, as assessed by modulation of downstream signaling molecules (e.g. phosphorylation status and/or degradation of key components of the TLR pathway).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Ghia, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741695
- Sponsor's protocol ID
- PS-CLL016
- Acronym
- PS-CLL016
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Delvecchio VS, Sana I, Mantione ME, Vilia MG, Ranghetti P, Rovida A, Angelillo P, Scarfo L, Ghia P, Muzio M. Interleukin-1 receptor-associated kinase 4 inhibitor interrupts toll-like receptor signalling and sensitizes chronic lymphocytic leukaemia cells to apoptosis. Br J Haematol. 2020 May;189(3):475-488. doi: 10.1111/bjh.16386. Epub 2020 Feb 14.
PubMed 32057093
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting IRAK4 in Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT07741695
- Acronym / sponsor ID
- PS-CLL016 / PS-CLL016
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Keywords
- chronic lymphocytic leukemia, IRAK4
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 3 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.
Patients with chronic lymphocytic leukemia (CLL) followed at Strategic Research Program on CLL will be enrolled and undergo sampling of additional amount of blood at the time of standard blood tests. Leukemic B cells and peripheral blood mononuclear cells (PBMC).
Detailed description
Patients with chronic lymphocytic leukemia (CLL) followed at Strategic Research Program on CLL will be enrolled and undergo sampling of additional amount of blood at the time of standard blood tests. Leukemic B cells and peripheral blood mononuclear cells (PBMC). Up to 50 ml of blood will be collected for the research project at the time of standard blood tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Procedure: Peripheral blood sample collectionCollection of peripheral blood (up to 50 ml) for the analysis of the biological activity of IRAK4 Chimeric Degradation Activation Compound (CDAC) in purified CLL B cells, assessed by changes in proliferation, apoptosis, and signaling pathway activation following in vitro treatment. |
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 followed at Strategic Research Program on CLL
Key inclusion criteria (3 listed)
- Age ≥18 years
- Diagnosis of CLL
- Participant is willing and able to 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral blood sample collectionUp to 50 ml of blood will be collected for the research project at the time of standard blood tests. | Procedure or surgery | Study cohort |
Primary outcome
TLR signaling
Time frame: 12 months
In vitro inhibition of TLR signaling in CLL cells following exposure to IRAK4 CDAC, as assessed by modulation of downstream signaling molecules (e.g. phosphorylation status and/or degradation of key components of the TLR pathway).
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 4 Aug 2026.
- Background: PubMed 32057093Delvecchio VS, Sana I, Mantione ME, Vilia MG, Ranghetti P, Rovida A, Angelillo P, Scarfo L, Ghia P, Muzio M. Interleukin-1 receptor-associated kinase 4 inhibitor interrupts toll-like receptor signalling and sensitizes chronic lymphocytic leukaemia cells to apoptosis. Br J Haematol. 2020 May;189(3):475-488. doi: 10.1111/bjh.16386. Epub 2020 Feb 14.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia (CLL), run by IRCCS San Raffaele.
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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Paolo Ghia, MD, PhD (+390226434797, ghia.paolo@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TLR signaling (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07741695, which also lists 1 linked publication.
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 4 Aug 2026.