Targeting IRAK4 in Chronic Lymphocytic Leukemia (PS-CLL016)

August 3, 2026 updated by: Paolo Ghia, IRCCS San Raffaele
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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients with CLL followed at Strategic Research Program on CLL

Description

Inclusion Criteria:

  • Age ≥18 years
  • Diagnosis of CLL
  • Participant is willing and able to 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Peripheral blood sample collection
Up to 50 ml of blood will be collected for the research project at the time of standard blood tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

July 29, 2026

First Submitted That Met QC Criteria

July 29, 2026

First Posted (Actual)

August 3, 2026

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS-CLL016

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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