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NCT Number: NCT07691047

Reassessment of the Risk of Hemolytic Syndrome in Patients With Chronic Lymphocytic Leukemia Treated With a Regimen Containing Venetoclax

Chronic lymphocytic leukemia is a malignant blood disorder characterized by the proliferation of abnormal B lymphocytes in the blood, lymph nodes, and bone marrow. It generally occurs after age 70 and is the fourth most common blood cancer in France, following multiple myeloma, diffuse large B-cell lymphoma, and myelodysplastic syndromes.

Treatments have advanced since 2015 with the introduction of immunotherapy and targeted therapies. The BCL2 inhibitor (venetoclax) is one of these innovative treatments. It is recommended as first-line therapy and for relapse in combination with anti-CD20 monoclonal antibodies and Bruton's tyrosine kinase inhibitors. Early studies showed that initial administration of venetoclax as monotherapy could lead to lysis syndrome as early as the first few days of treatment. This risk was correlated with the venetoclax dose and tumor burden. Prevention guidelines were subsequently proposed to guide management. This risk is therefore assessed before treatment begins (low, moderate, high), based on lymph node size and circulating lymphocyte count.

For patients at moderate and high risk, a treatment strategy is recommended that includes hyperhydration and uric acid-lowering agents, which may require hospitalization in some cases. The introduction of combination therapies has improved the depth and duration of response (obinutuzumab + venetoclax and ibrutinib + venetoclax). Venetoclax is added after the initiation of partner agents (22 days after obinutuzumab and 3 cycles after ibrutinib). This initial phase of treatment may reduce the risk of hemolytic syndrome. We propose here to reassess the risk of hemolytic syndrome before starting venetoclax in order to simplify management.

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Key information

Conditions

Chronic Lymphoid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique de l'Europe, Amiens, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with chronic lymphocytic leukemia/lymphocytic lymphoma
  • Meeting the treatment criteria according to iwCLL 2018
  • Eligible for treatment with venetoclax in combination with a Bruton's tyrosine kinase inhibitor (ibrutinib, other approved generations) or obinutuzumab
  • First-line treatment or relapse

Exclusion criteria

  • Patients with meningeal and/or cerebral involvement
  • Patients with an active, uncontrolled infection
  • Patients scheduled to receive venetoclax monotherapy or rituximab-venetoclax according to the MURANO study regimen (Murano regimen: venetoclax is administered before rituximab)
  • Contraindications to contrast-enhanced CT scanning (severe renal insufficiency, documented allergy to contrast agents).
  • Pregnancy or breastfeeding
  • Individuals deprived of their liberty, under legal guardianship, or under conservatorship
  • Dementia, mental impairment, or psychiatric disorder that could compromise the patient's ability to provide informed consent and/or to adhere to the protocol and follow-up requirements of the trial

Treatment and study plan

Cervical, Thoracic, Abdominal, and Pelvic CT Scan

Procedure

Cervical, Thoracic, Abdominal, and Pelvic CT Scan

Primary outcomes

  1. risk level for tumor lysis syndrome

    Time frame: Basal - 7 days before introduction of Venetoclax

    SLT is defined as any clinical and/or biological manifestation related to the destruction of tumor cells. It can be spontaneous (related to rapid disease progression, a rare occurrence in CLL) or treatment-induced.

    Clinical SLT may involve renal failure with decreased urine output and lower extremity edema, cardiac arrhythmias, fever, and seizures; its intensity may vary depending on severity.

    Biochemical SLT is defined by the presence of hyperkalemia, elevated serum creatinine levels, hyperuricemia, hyperphosphatemia, or hypocalcemia.

Secondary outcomes

  1. Event-free survival

    Time frame: From enrollment until the first event of interest, assessed up to 26 months.

    Event free survival defined as the time from the date of enrollment to the date of the first event of interest. The events of interest in the study are: treatment reduction or discontinuation, relapse or disease progression, death, and any grade ≥ 3 event.

  2. Change from baseline in EORTC QLQ-CLL17 total score

    Time frame: Baseline, Month 3, Month 6, and end of treatment (up to 26 months).

    Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Chronic Lymphocytic Leukemia questionnaire (EORTC QLQ-CLL17). Scores are linearly transformed to a 0-100 scale. Higher symptom scores indicate greater symptom burden and therefore a worse outcome, whereas higher functioning scores indicate better functioning and therefore a better outcome.

  3. Progression-free survival

    Time frame: From enrollment until disease progression or death, assessed up to 26 months.

    Progression-free survival is defined as the time from enrollment to the first documented disease progression according to iwCLL criteria or death from any cause, whichever occurs first. Patients without progression or death will be censored at the date of their last disease assessment.

  4. Overall Survival

    Time frame: From enrollment until death from any cause, assessed up to 26 months.

    Overall survival is defined as the time from enrollment to death from any cause. Patients who are alive at the time of analysis will be censored at the date of last known contact.

  5. Overall Response Rate

    Time frame: End of treatment (up to 26 months).

    Overall response rate is defined as the proportion of patients achieving a complete response (CR) or partial response (PR) at the end of treatment according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.

  6. Treatment Reduction or Discontinuation Rate

    Time frame: From treatment initiation to end of treatment (up to 26 months).

    Proportion of patients with reduction or discontinuation of intravenous or oral treatment for any reason among the intention-to-treat population.

Study contacts

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

Marion Mandon, PhD

CONTACT

[email protected]

+33 6 78 27 76 72

Sponsors and collaborators

Lead sponsor

Private Hospital of Confluent, France

Other

Registry information

Acronym: ELYSA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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