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A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

RecruitingPhase 3Ages 18 Years - anyAllAbbVie
NCT06428019 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed. Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 170 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide. Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab,

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of \> 6 months. * Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for eligibility, screening, treatment and evaluation. * Eastern Cooperative Oncology Group (ECOG) performance status \<= 2. * Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL as listed in the protocol. * Creatinine clearance (CrCl) \>= 30 mL/min using the Cockcroft-Gault formula are eligible for inclusion. Exclusion Criteria: \- Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia.
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What it tests

  • Venetoclax
  • Acalabrutinib
  • Obinutuzumab
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Where

70 sites
Arizona Oncology - Tucson - Rudasill /ID# 267552
Tucson, United States
Southern VA Health Care System /ID# 266254
Tucson, United States
UCSF FRESNO/Community Cancer Institute /ID# 270874
Clovis, United States
Valkyrie Clinical Trials /ID# 268151
Los Angeles, United States
Rocky Mountain Cancer Centers - Aurora /ID# 267549
Aurora, United States
Yale University School of Medicine /ID# 266224
New Haven, United States
Malcolm Randall V.A. Medical Center /ID# 267825
Gainesville, United States
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 266713
Jacksonville, United States

…and 62 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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