A study to assess the real-life management and use of healthcare resources during the initiation of: * Venetoclax in combination with rituximab is indicated for the treatment of adult participants with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. * Venetoclax in participants with CLL with the deletion of the short arm of chromosome 17 (del\[17p\]) who have received at least 1 prior therapy or participants with CLL without del(17p) who have received at least 1 prior therapy and for whom there are no other available treatment options.
Study Type
OBSERVATIONAL
Enrollment
93
University of Calgary /ID# 166416
Calgary, Alberta, Canada
Cross Cancer Institute /ID# 166417
Edmonton, Alberta, Canada
Jack Ady Cancer Centre /ID# 217491
Lethbridge, Alberta, Canada
CancerCare Manitoba /ID# 170751
Winnipeg, Manitoba, Canada
The Moncton Hospital /ID# 166043
Moncton, New Brunswick, Canada
QE II Health Sciences Centre /ID# 213548
Halifax, Nova Scotia, Canada
William Osler Health System /ID# 202049
Brampton, Ontario, Canada
Health Sciences North /ID# 205817
Greater Sudbury, Ontario, Canada
Kingston Health Sciences Centre /ID# 169252
Kingston, Ontario, Canada
Ottawa Hospital Research Institute /ID# 166041
Ottawa, Ontario, Canada
...and 3 more locations
Duration of Prophylactic Hospitalization
Duration of prophylactic hospitalization is defined as the date of discharge - the date of admission + 1.
Time frame: Up to approximately 6 weeks
Number of Hours from Dosing to Blood Draw
Number of hours between laboratory assessments and the first dose of each ramp-up dose for venetoclax
Time frame: Baseline (Day 0)
Intravenous (IV) fluid hydration
Type of IV fluid participant was on hydration, rate and duration are assessed.
Time frame: Up to 24 weeks after first dose of venetoclax
Percent of Participants with Tumor Burden of Low, Medium, and High
Percent of participants with tumor burden of low, medium, and high.
Time frame: Baseline (Day 0)
Other Actions Taken within the First 24 Hours of each Dose Ramp-up
Other actions taken within the first 24 hours of each dose ramp-up, for example, prophylaxis treatment
Time frame: Up to approximately 6 weeks
Change from Baseline in Health Care Resource Utilization (HCRU)
HCRU will be evaluated using self-administered questionnaire aimed at measuring the patient's health care resource utilization.
Time frame: Up to 24 weeks after first dose of venetoclax
Change in Metabolites Post Dose
Change in metabolites (potassium, creatinine, uric acid, phosphorus, calcium) post dose.
Time frame: Up to 24 weeks after first dose of venetoclax
Percentage of Participants with Prophylactic Hospitalization
Percentage of participants with prophylactic hospitalization is defined as the percentage of participants who are hospitalized for prophylactic measures.
Time frame: Up to approximately 6 weeks
Reasons for Dose Interruptions
Reasons for dose interruptions.
Time frame: Up to 24 weeks after first dose of venetoclax
Change in Creatinine Clearance
Change in creatinine clearance is defined as the change of creatinine clearance from Baseline (Day 0).
Time frame: Up to 24 weeks after first dose of venetoclax
Number of Hours for Dose Interruptions
Number of hours for dose interruptions is defined as the duration of dose interruptions in hours. If more than one does interruption occurs, the total number of hours for dose interruption will be calculated.
Time frame: Up to 24 weeks after first dose of venetoclax
Number of Weeks for Ramping up Venetoclax Dose to 400 mg daily (QD) or maximum dose reached
Number of weeks for ramping up to Venetoclax 400 mg QD or maximum dose reached as the duration of the ramping-up period in weeks.
Time frame: Up to approximately 6 weeks
Number of Days on Each Dose of Venetoclax
Number of days on each dose of venetoclax is defined as the date of first exposure to the dose - the date of the last exposure to the dose + 1.
Time frame: Up to 24 weeks after first dose of venetoclax
Percentage of Participants with Other Mutations
Percentage of participants with other mutations.
Time frame: Baseline (Day 0)
Weeks since Last CLL Relapse
Duration of time from most recent CLL relapse and Baseline (Day 0).
Time frame: Baseline (Day 0)
Percentage of Participants with Major Co-Morbidities
Percentage of participants with major co-morbidities including medical history/surgery and transplant prior to Baseline (Day 0).
Time frame: Baseline (Day 0)
Percentage of Participants with Exposure to Ibrutinib and/or Idelalisib Prior to Baseline
Participants with previous exposure to ibrutinib and/or idelalisib prior to Baseline (Day 0).
Time frame: Baseline (Day 0)
Change from Baseline in EORTC QLQ-C30 Scores
Change from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores.
Time frame: Up to 24 weeks after first dose of venetoclax
Change from Baseline in Eastern Cooperative Oncology Group Performance Status
Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.
Time frame: Up to 24 weeks after first dose of venetoclax
Change from Baseline in QLQ-CLL17 Scores
Change from baseline in Quality of Life Questionnaire - Chronic Lymphocytic Leukemia (QLQ-CLL)17 scores.
Time frame: Up to 24 weeks after first dose of venetoclax
Weeks Since Initiating First Line of Therapy for CLL
Duration of time in weeks from date of first line of therapy administered for CLL to Baseline (Day 0).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline (Day 0)
Percent of Participants at Each Stage in the Rai Staging System
Percent of participants at each stage in the Rai Staging System for CLL.
Time frame: Baseline (Day 0)
Percentage of Participants with Del(17p)
Percentage of participants with the deletion of the short arm of chromosome 17 (Del\[17p\]).
Time frame: Baseline (Day 0)
Percent of Participants at Each Stage in the Binet Staging System
Percent of participants at each stage in the Binet Staging System for CLL.
Time frame: Baseline (Day 0)
Number of Prior Lines of Therapy for CLL
Number of prior lines of therapy for CLL before initiating administration with venetoclax.
Time frame: Baseline (Day 0)
Years to Treatment from Initial Diagnosis of Chronic Lymphocytic Leukemia (CLL)
Years to treatment with venetoclax (Baseline, Day 0) from initial diagnosis of CLL.
Time frame: Baseline (Day 0)
Weeks since the Last Line of Therapy (Agent) for CLL Prior to Baseline
Duration of time in weeks since line of therapy (agent) administered for CLL prior to Baseline (Day 0).
Time frame: Baseline (Day 0)
Weeks since First CLL Relapse
Duration of time in weeks from diagnosis of CLL to first relapse.
Time frame: Baseline (Day 0)