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NCT Number: NCT05610228

Study of the Metabolism in the Lymphatic Niche of CLL

Chronic lymphoid leukemia (CLL) is the most common adult leukemia that is characterized by a malignant monoclonal accumulation of tumoral and quiescent B cells in the peripheral blood. In advanced stages of the disease (Binet stage C), this population invades the bone marrow (BM) and proliferate into the lymphoid organs that results in widespread adenopathy. Richter's transformation is a most aggressive serious complication of CLL (transformation of the disease into an aggressive lymphoma) detected based on TEP/CT (Positron Emission Tomography/ computerized tomography) that shows highly derived glucose consumption by cancer cells. Clinical data from CLL patients with disease acutisation showed hypermetabolic lymphadenopathy with high standardized uptake value (SUV) whereas there is low grade tracer uptake into BM. We supposed that the tumor microenvironment of the lymphatic niche promotes the proliferation and glycolytic activity of CLL cells which become particularly resistant to treatment. The development of an ex-vivo tumor model that reproduces the microenvironment of the lymph node niche appears essential to identify and validate new therapeutic targets because despite the therapeutic arsenal available some patients still relapse or are refractory to treatment. Our objectives are to i / Characterize this niche of resistance by the development of an ex-vivo tumor model and ii / Evaluate in-vitro the effectiveness of the association of current treatments (RFC, Ibrutinib or Venetoclax) with anti-metabolic therapies (inhibitors of glycolysis) Our lab is developing an ex-vivo models of the lymphatic niche in CLL based on co-cultures of leukemic cells from patients stimulated with CpG ODN and IL2 with primary human lymphatic fibroblasts (HLF) (EC 12PP15). This co-culture has never been described in the literature and allows us to study the lymphatic niche of CLL patients. Lymph node (LN) exploration in CLL requires invasive access and does not bring any additional information in initial diagnosis. Then, we validated our co-culture model using complementary approaches: increased viability, proliferation, and resistance to Ibrutinib, associated with increased production of anti-apoptotic proteins such as MCL1 and BCL2 after 48 hours of co-culture. Secondly, we studied the metabolism in this resistance niche. We find an increased production of lactate and an acute consumption of glucose, associated with a strong metabolic activation detected by SEAHORSE and by the production of glycolysis enzymes such as hexokinase 2. Our study constitutes an original project because it characterized the energy metabolism of the CLL lymphatic niche by developing an original ex-vivo model and enhanced our understanding of the contribution of the specific microenvironment in the dissociation of metabolic activity using SUV max in BM and lymphatic niche. Anti-metabolic therapies are efficient on co-culture CLL cells and could be an alternative for refractory or relapsed patients under current treatment.

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Key information

Conditions

CLL

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nice University Hospital

Nice, 06000, France

Location status: Recruiting

Location contact

Caroline Ruetsch-Chelli

CONTACT

[email protected]

0492039016

Caroline ruetsch-Chelli

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients for whom the diagnosis of CLL has been established cytologically and phenotypically (Matutes score)
  • Patients over 18 years old
  • Patients who have signed the non-objection form
  • Untreated patients

Exclusion criteria

  • Patient with a solid cancer that is progressive or in remission for less than 3 years
  • HIV positive patients
  • Patients with chronic active hepatitis B or C
  • History of allogeneic transplant

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Modelisation of a CLL lymphatic niche by creation of an ex-vivo model

    Time frame: 48 months

    Measure of viability and proliferation of CLL cells by annexin PI with multiparameter:

    flow cytometry device, western blot and validation of the model by testing current therapy (Ibrutinib, anti BTK inhibitor)

  2. Study of metabolism in CLL ex-vivo model

    Time frame: 48 months

    Anlayse of metabolism (ECAR and OCR) by seahorse methods , PCR qnd protein Multiparameter analyse

  3. Evaluate in-vitro the effectiveness of the combination of current treatments (RFC, Ibrutinib or Venetoclax) with anti-inflammatory therapies. -metabolic (glycolysis inhibitors)

    Time frame: 48 months

    Viability using multiparameter flow cytometry

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Ruetsch-Chelli

CONTACT

[email protected]

33492039016

Marcel Deckert

CONTACT

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Study of the Metabolic Reprogramming of CLL Cells in Ex-vivo Models of the Lymphatic Niche

Important dates

Study start
2018
Primary completion
2022
Study completion
2027
First posted
Nov 9, 2022
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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