NCT07741695

Brief 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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
12mo left

Started Sep 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 29, 2026

Last Update Submit

July 29, 2026

Conditions

Keywords

chronic lymphocytic leukemiaIRAK4

Outcome Measures

Primary Outcomes (1)

  • 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).

    12 months

Study Arms (1)

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

Interventions

Up to 50 ml of blood will be collected for the research project at the time of standard blood tests.

Study cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with CLL followed at Strategic Research Program on CLL

You may qualify if:

  • Age ≥18 years
  • Diagnosis of CLL
  • Participant is willing and able to give informed consent for participation in the study.

You may not qualify if:

  • \) Participant is unable or unwilling to provide informed consent for participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32057093BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Paolo Ghia, MD, PhD

CONTACT

Lydia Scarfo, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 3, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

August 3, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share