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

Condition(s) studied

Investigational drug(s) / intervention(s)

Cervical, Thoracic, Abdominal, and Pelvic CT Scan: Cervical, Thoracic, Abdominal, and Pelvic CT Scan

Study 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 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.

Eligibility

Primary outcome measure(s)

• risk level for tumor lysis syndrome — 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.

Trial sites (2)

More Private Hospital of Confluent, France trials in France

Other trials for the same condition