Reassessment of the Risk of Hemolytic Syndrome in Patients With Chronic Lymphocytic Leukemia Treated With a Regimen Containing Venetoclax
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Diagnoza przewlekłej białaczki limfocytowej lub chłoniaka limfocytowego
- •Spełnianie kryteriów do rozpoczęcia leczenia
- •Kwalifikacja do leczenia venetoclaxem w kombinacji z innymi lekami (ibrutinib lub obinutuzumab)
- •Leczenie jako pierwsza linia lub wznowienie leczenia po wcześniejszej terapii
✗ Disqualifies
- •Zajęcie mózgu lub opon mózgowych
- •Aktywna, niekontrolowana infekcja
- •Zaplanowane leczenie venetoclaxem samym lub w konkretnym schemacie z rituximabem
- •Bezwzględne przeciwwskazania do badania CT z kontrastem (ciężkie problemy z nerkami, alergia na kontrast)
- •Ciąża lub karmienie piersią
- •Ograniczenie wolności (pozbawienie wolności, kuratela, opiekuństwo)
- •Demencja, upośledzenie umysłowe lub zaburzenia psychiczne uniemożliwiające świadomą zgodę i uczestnictwo w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 13, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (2)
Clinique de l'Europe
Amiens, France
Hôpital Privé du Confluent
Nantes, France
Trial contact
Marion Mandon, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/14/2026.
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