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)
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Registration Number
- 2024-512147-23-00
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
To evaluate the incidence of treatment-emergent laboratory TLS per Howard criteria or treatment-emergent hyperkalemia (potassium > 6.0 mmol/L), both requiring clinical intervention that has been confirmed by an Independent Review Committee (IRC) assessment in previously untreated subjects with CLL achieving either a medium tumor burden with CrCl of at least 80 mL/min or low tumor burden (regardless of CrCl level) after debulking therapy, during the venetoclax ramp-up period (5-, 6- or 7-week).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Not specified
- Target Recruitment
- 115
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
Active/uncontrolled infection or Richter's transformation or active immune thrombocytopenia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm D: Venetoclax + Acalabrutinib Acalabrutinib Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up B. Arm D: Venetoclax + Acalabrutinib Venetoclax Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up B. Arm A: Venetoclax + Obinutuzumab Obinutuzumab Participants will receive venetoclax in combination with obinutuzumab, with a 5 week venetoclax ramp up. Arm A: Venetoclax + Obinutuzumab Venetoclax Participants will receive venetoclax in combination with obinutuzumab, with a 5 week venetoclax ramp up. Arm B: Venetoclax + Acalabrutinib Venetoclax Participants will receive venetoclax in combination with acalabrutinib, with a 5 week venetoclax ramp up. Arm B: Venetoclax + Acalabrutinib Acalabrutinib Participants will receive venetoclax in combination with acalabrutinib, with a 5 week venetoclax ramp up. Arm C: Venetoclax + Acalabrutinib Venetoclax Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up A. Arm C: Venetoclax + Acalabrutinib Acalabrutinib Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up A.
- Primary Outcome Measures
Name Time Method Part 1: Incidence of treatment-emergent laboratory TLS or treatment-emergent hyperkalemia per Howard criteria that require a clinical intervention that has been confirmed by an IRC assessment Part 1: Incidence of treatment-emergent laboratory TLS or treatment-emergent hyperkalemia per Howard criteria that require a clinical intervention that has been confirmed by an IRC assessment
Reduction of Tumor Burden from Baseline Reduction of Tumor Burden from Baseline
- Secondary Outcome Measures
Name Time Method Part 1: The incidence of treatment-emergent laboratory TLS or treatment-emergent hyperkalemia per Howard criteria that require a clinical intervention that has confirmed by an IRC assessment Part 1: The incidence of treatment-emergent laboratory TLS or treatment-emergent hyperkalemia per Howard criteria that require a clinical intervention that has confirmed by an IRC assessment
Part 1: Incidence of Laboratory TLS per Howard criteria that require a clinical intervention that has been confirmed by an IRC assessment Part 1: Incidence of Laboratory TLS per Howard criteria that require a clinical intervention that has been confirmed by an IRC assessment
Part 1: Incidence of Hyperkalemia per Howard criteria that require a clinical intervention that has been confirmed by an IRC assessment Part 1: Incidence of Hyperkalemia per Howard criteria that require a clinical intervention that has been confirmed by an IRC assessment
Part 1: Incidence of Laboratory TLS per Howard criteria irrespective of clinical intervention Part 1: Incidence of Laboratory TLS per Howard criteria irrespective of clinical intervention
Part 1: Incidence of Hyperkalemia irrespective of clinical intervention Part 1: Incidence of Hyperkalemia irrespective of clinical intervention
Part 1: Incidence of Clinical TLS per Howard criteria irrespective of clinical intervention Part 1: Incidence of Clinical TLS per Howard criteria irrespective of clinical intervention
Part 1: Incidence of any single TLS-related lab abnormality requiring clinical intervention per Investigator (Hyperuricemia or Hyperphosphatemia or Hyperkalemia or Hypocalcemia) Part 1: Incidence of any single TLS-related lab abnormality requiring clinical intervention per Investigator (Hyperuricemia or Hyperphosphatemia or Hyperkalemia or Hypocalcemia)
Adverse Events (AE) of TLS Adverse Events (AE) of TLS
Reduction of tumor burden from baseline Reduction of tumor burden from baseline
Trial Locations
- Locations (65)
Arizona Oncology - Tucson - Rudasill /ID# 267552
🇺🇸Tucson, Arizona, United States
Southern VA Health Care System /ID# 266254
🇺🇸Tucson, Arizona, United States
UCSF FRESNO/Community Cancer Institute /ID# 270874
🇺🇸Clovis, California, United States
Valkyrie Clinical Trials /ID# 268151
🇺🇸Los Angeles, California, United States
Rocky Mountain Cancer Centers - Aurora /ID# 267549
🇺🇸Aurora, Colorado, United States
Yale University School of Medicine /ID# 266224
🇺🇸New Haven, Connecticut, United States
Malcolm Randall V.A. Medical Center /ID# 267825
🇺🇸Gainesville, Florida, United States
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 266713
🇺🇸Jacksonville, Florida, United States
Mid Florida Hematology And Oncology Center /ID# 269159
🇺🇸Orange City, Florida, United States
Comprehensive Hematology Oncology /ID# 267644
🇺🇸Saint Petersburg, Florida, United States
Scroll for more (55 remaining)Arizona Oncology - Tucson - Rudasill /ID# 267552🇺🇸Tucson, Arizona, United States