Lymph Node Microenvironment Modifications in Patients With CLL Treated With Venetoclax-based Regimens

Sponsor
Paolo Ghia
Study ID
NCT04790045
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Core-needle biopsy to be performed before starting treatment in patients candidates to venetoclax-based regimens

Study Details

CLL subjects who should receive treatment with a venetoclax-based regimen as per standard of care will be enrolled into this trial, after providing informed consent. The following evaluations will be performed baseline before starting treatment: Baseline assessments: In addition to standard staging procedures before treatment initiation, including blood tests and BM aspirate and biopsy, the following procedures will be performed per protocol: * Peripheral blood sample drawing for pharmacodynamics studies, MRD assessment and cfDNA evaluation * Ultrasound-guided lymph node CNB * Tailored ultrasound evaluation of nodal sites and spleen * Bone marrow MRD sample drawing (optional) The nodal site for the biopsy will be selected based on the size (the largest nodal lesion will be considered) and the procedure feasibility (only superficial cervical, axillary or inguinal lymph nodes will be considered suitable for biopsy). On treatment assessments: Peripheral blood sampling and ultrasound-guided lymph node CNB will be repeated in patients on venetoclax-based therapy: * 7 days after completion of venetoclax ramp up phase, * +12 months after completion of venetoclax ramp-up phase. Patients with residual lymph nodes that are not suitable for ultrasound-guided lymph node CNB will continue the ultrasound monitoring only Patients will follow an intensive ultrasound monitoring schedule, which requires tailored ultrasound evaluation being repeated at the following timepoints: * 4 weeks after venetoclax ramp-up completion * Every 2 months thereafter until disease progression or unacceptable toxicity leading to permanent treatment discontinuation. Assessments at progression: A tailored ultrasound of nodal sites and spleen will be performed within 2 weeks from the first signs and/or symptoms of suspected progression. US assessment can be delayed at Investigator's discretion in case pseudo-progression is suspected based on potentially confounding concomitant conditions, e.g. infection. In progressive cases, the same assessments (including BM aspirate and biopsy) will be repeated at the time of disease progression. In patients progressing with bulky lymph nodes an incisional lymph node biopsy (instead of an ultrasound-guided CNB) will be performed to exclude Richter's transformation as per standard of care.

Key Dates

Start date
Nov 1, 2023
Status verified
Oct 2023
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Venetoclax-based treatment
    Single-arm study Patients enrolled will be receiving venetoclax-based regimens according to the standard of care

Primary Outcome Measure

To evaluate lymph node changes in CLL patients treated with venetoclax-based regimens both at molecular level [ Time Frame: 24 months ]

Related Studies