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

NCT07691047 | Not Yet Recruiting

• 1 other identifier: 2025-50-HPC
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Lymphoid Leukemia

Keywords

chronic lymphoid leukemia; venetoclax; lysis syndrome

Outcome Measures

Primary Outcomes (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.

  Basal - 7 days before introduction of Venetoclax

Secondary Outcomes (6)

• Event-free survival

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

• Change from baseline in EORTC QLQ-CLL17 total score

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

• Progression-free survival

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

• Overall Survival

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

• Overall Response Rate

  End of treatment (up to 26 months).

Study Arms (1)

reassessment of risk of hemolytic syndrome

EXPERIMENTAL

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

Interventions

Cervical, Thoracic, Abdominal, and Pelvic CT Scan PROCEDURE

Cervical, Thoracic, Abdominal, and Pelvic CT Scan

reassessment of risk of hemolytic syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Private Hospital of Confluent, France: lead

Study Sites (2)

Clinique de l'Europe

Amiens, France

Location

Hôpital Privé du Confluent

Nantes, France

Location

MeSH Terms

Conditions

Leukemia, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Marion Mandon, PhD

CONTACT

+33 6 78 27 76 72; mmandon@vivalto-sante.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 8, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)