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

6. juli 2026 opdateret af: Private Hospital of Confluent, France

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

130

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Amiens, Frankrig
        • Clinique de l'Europe
        • Kontakt:
      • Nantes, Frankrig
        • Hopital Prive Du Confluent
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: reassessment of risk of hemolytic syndrome
Procedure: Cervical, Thoracic, Abdominal, and Pelvic CT Scan
Cervical, Thoracic, Abdominal, and Pelvic CT Scan

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
risk level for tumor lysis syndrome
Tidsramme: 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.
Basal - 7 days before introduction of Venetoclax

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Event-free survival
Tidsramme: 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.
From enrollment until the first event of interest, assessed up to 26 months.
Change from baseline in EORTC QLQ-CLL17 total score
Tidsramme: 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.
Baseline, Month 3, Month 6, and end of treatment (up to 26 months).
Progression-free survival
Tidsramme: 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.
From enrollment until disease progression or death, assessed up to 26 months.
Overall Survival
Tidsramme: 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.
From enrollment until death from any cause, assessed up to 26 months.
Overall Response Rate
Tidsramme: 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.
End of treatment (up to 26 months).
Treatment Reduction or Discontinuation Rate
Tidsramme: 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.
From treatment initiation to end of treatment (up to 26 months).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Private Hospital of Confluent, France

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. juli 2026

Primær færdiggørelse (Anslået)

31. juli 2029

Studieafslutning (Anslået)

30. september 2029

Datoer for studieregistrering

Først indsendt

29. juni 2026

Først indsendt, der opfyldte QC-kriterier

6. juli 2026

Først opslået (Faktiske)

8. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-50-HPC

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Cervical, Thoracic, Abdominal, and Pelvic CT Scan

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