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)

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

Trial Details

NCT ID
NCT06428019
Phase
PHASE3
Sponsor
AbbVie
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Venetoclax
  • Acalabrutinib
  • Obinutuzumab
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Clovis, California, United States|36.82523,-119.70292
  • Los Angeles, California, United States|34.05223,-118.24368
  • Aurora, Colorado, United States|39.72943,-104.83192

Key Eligibility Criteria

  • Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop …
  • Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for elig…
  • 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 involve…

For full eligibility, visit ClinicalTrials.gov.

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