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Chronic Lymphoid LeukemiaELYSANCT07691047

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

A study testing Cervical, Thoracic, Abdominal, and Pelvic CT Scan in people with Chronic Lymphoid Leukemia, run by Private Hospital of Confluent, France at 2 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphoid Leukemia
What is being tested?
Cervical, Thoracic, Abdominal, and Pelvic CT Scan
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
2 sitesFrance
Study dates
30 Sep 2026to 30 Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Marion Mandon, PhD contact

+33 6 78 27 76 72

mmandon@vivalto-sante.com

France2 sites, 2 recruiting

  • Clinique de l'Europe

    Amiens

    Marion Mandon, PhD, +33 6 78 27 76 72, drc@vivalto-sante.com

    Not yet recruiting

  • Hôpital Privé du Confluent

    Nantes

    Marion Mandon, PhD, +33 6 78 27 76 72, drc@vivalto-sante.com

    Recruiting

Other trials in France

About this study

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.

Being tested
Cervical, Thoracic, Abdominal, and Pelvic CT Scan
Keywords
chronic lymphoid leukemia, venetoclax, lysis syndrome
Medical subject headings
Leukemia, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervical, Thoracic, Abdominal, and Pelvic CT ScanProcedure or surgery

    Cervical, Thoracic, Abdominal, and Pelvic CT Scan

Study groups in NCT07691047
Study groupRoleWhat they receive
reassessment of risk of hemolytic syndromeExperimentalNot described
Receives: Procedure: Cervical, Thoracic, Abdominal, and Pelvic CT Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. risk level for tumor lysis syndrome

    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.

    Measured: Basal - 7 days before introduction of Venetoclax

Secondary outcomes (6)

  1. Event-free survival

    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.

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

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

    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.

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

  3. Progression-free survival

    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.

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

  4. Overall Survival

    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.

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

  5. Overall Response Rate

    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.

    Measured: End of treatment (up to 26 months).

  6. Treatment Reduction or Discontinuation Rate

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2026
  2. Study start30 Sep 2026
  3. Primary completion31 Jul 2029 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07691047
Sponsor's protocol ID
2025-50-HPC
Acronym
ELYSA
Status last verified
Oct 2026
First submitted
29 Jun 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cervical, Thoracic, Abdominal, and Pelvic CT Scan in people with Chronic Lymphoid Leukemia, run by Private Hospital of Confluent, France at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marion Mandon, PhD (+33 6 78 27 76 72, mmandon@vivalto-sante.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

risk level for tumor lysis syndrome (time frame: Basal - 7 days before introduction of Venetoclax). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07691047.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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