changes in lymph nodes in patients with CLL treated with venetoclax-containing regimens

Lymph Node Microenvironment Modifications in Patients with CLL Treated with Venetoclax-based regimens - LymBIO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000722-96-IT

Enrollment

Registered

2021-06-08

Start date

2022-02-09

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia MedDRA version: 21.0 Level: LLT Classification code 10009310 Term: CLL System Organ Class: 100000004864

Interventions

Trade Name: venclyxto Product Name: Venclyxto Product Code: [Venclyxto] Pharmaceutical Form: Coated tablet INN or Proposed INN: venetoclax CAS Number: 1257044-40-8 Current Sponsor code: venetoclax Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of CLL 2. Candidate patients for treatment with venetoclax-based regimens 3. Basal value of platelets> 100x109 / l 4. PT INR and aPTT within the limits Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: 1. Patients receiving antiplatelet and / or anticoagulant therapy that cannot be safely stopped prior to biopsy

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate changes in lymph nodes in patients with CLL treated with venetoclax-containing regimens at both the molecular and ultrasound level;Secondary Objective: ¿ To evaluate CLL cell changes in PB in CLL patients treated with venetoclax-based regimens ¿ Correlate changes in the lymph node microenvironment and CLL cells from LN and PB with response to treatment and clinical course ¿ Evaluate lymph node characteristics in patients with CLL treated with venetoclax-based regimens who achieve undetectable (<10-4) vs detectable (=10-4) MRD status, ¿ To evaluate lymph node characteristics in patients with CLL treated with venetoclax-based regimens that achieve complete (CR) or partial (PR) response;Primary end point(s): - Characterization by immunohistochemistry, gene expression profile, protein expression and proliferative activity of CLL lymphocytes and LN-derived accessory cells of CLL patients treated with venetoclax-based regimens 12 months after completion of the venetoclax ramp-up phase - Definition of ultrasound characteristics of LNs in CLL patients treated with venetoclax-based regimens 12 months after completion of the venetoclax acceleration phase;Timepoint(s) of evaluation of this end point: 12 months after completion of venetoclax acceleration phase	—

Measure

Time frame

Main Objective: Evaluate changes in lymph nodes in patients with CLL treated with venetoclax-containing regimens at both the molecular and ultrasound level;Secondary Objective: ¿ To evaluate CLL cell changes in PB in CLL patients treated with venetoclax-based regimens ¿ Correlate changes in the lymph node microenvironment and CLL cells from LN and PB with response to treatment and clinical course ¿ Evaluate lymph node characteristics in patients with CLL treated with venetoclax-based regimens who achieve undetectable (<10-4) vs detectable (=10-4) MRD status, ¿ To evaluate lymph node characteristics in patients with CLL treated with venetoclax-based regimens that achieve complete (CR) or partial (PR) response;Primary end point(s): - Characterization by immunohistochemistry, gene expression profile, protein expression and proliferative activity of CLL lymphocytes and LN-derived accessory cells of CLL patients treated with venetoclax-based regimens 12 months after completion of the venetoclax ramp-up phase - Definition of ultrasound characteristics of LNs in CLL patients treated with venetoclax-based regimens 12 months after completion of the venetoclax acceleration phase;Timepoint(s) of evaluation of this end point: 12 months after completion of venetoclax acceleration phase

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Secondary

Measure	Time frame
Secondary end point(s): Immuhistochemical characterization, gene expression profile, protein expression and proliferative activity of CLL lymphocytes and PB-derived accessory cells of CLL patients treated with venetoclax-based regimens 12 months after completion of the ramp-up phase up by venetoclax;Timepoint(s) of evaluation of this end point: 12 months after completion of venetoclax acceleration phase	—

Measure

Time frame

Secondary end point(s): Immuhistochemical characterization, gene expression profile, protein expression and proliferative activity of CLL lymphocytes and PB-derived accessory cells of CLL patients treated with venetoclax-based regimens 12 months after completion of the ramp-up phase up by venetoclax;Timepoint(s) of evaluation of this end point: 12 months after completion of venetoclax acceleration phase

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Countries

Italy

Contacts

Public ContactUfficio Data Management PS-CLL

Ospedale San Raffaele

ghia.paolo@hsr.it0226432611

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026