NCT04790045: LymBIO

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

Not yet recruiting Phase 4 Last updated 3 October 2023

What this trial tests

Phase 4 trial testing Venetoclax in Chronic Lymphocytic Leukemia in 30 participants. Not yet recruiting.

Timeline

1 November 2023

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Paolo Ghia
Phase	Phase 4
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 November 2023
Primary completion	31 December 2026
Estimated completion	31 December 2026

Drugs / interventions tested

• Venetoclax (venetoclax) — full drug profile →

Conditions studied

• Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →

Sponsor

Paolo Ghia — full company profile →

Who can join

18 and older, any sex, with Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Advancing Leukemia Management Through Liquid Biopsy: Insights into Biomarkers and Clinical Utility.
   Hollanda CN, Gualberto ACM, Motoyama AB, Pittella-Silva F. · · 2025 · cited 4× · PMID 40361366 · DOI 10.3390/cancers17091438