Status:
RECRUITING
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)
Lead Sponsor:
AbbVie
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 acalabrutini...
Eligibility Criteria
Inclusion
- 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
- \- Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia.
Key Trial Info
Start Date :
August 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06428019
Start Date
August 5 2024
End Date
March 1 2028
Last Update
November 5 2025
Active Locations (70)
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1
Arizona Oncology - Tucson - Rudasill /ID# 267552
Tucson, Arizona, United States, 85704
2
Southern VA Health Care System /ID# 266254
Tucson, Arizona, United States, 85723
3
UCSF FRESNO/Community Cancer Institute /ID# 270874
Clovis, California, United States, 93611
4
Valkyrie Clinical Trials /ID# 268151
Los Angeles, California, United States, 90067