Study to Describe the Management and the Use of Healthcare Resources in Patients With Chronic Lymphocytic Leukemia (CLL) Initiating Venetoclax in Routine Clinical Practice
- Conditions
- Chronic Lymphocytic Leukemia
- Registration Number
- NCT03310190
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- Patient's physician prescribed venetoclax as per product monograph independent of the patient participation in this study.
- Has chronic lymphocytic leukemia (CLL) and has received at least one prior therapy.
- Currently participating in an interventional study.
- Has other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of CLL.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of Prophylactic Hospitalization Up to approximately 6 weeks Duration of prophylactic hospitalization is defined as the date of discharge - the date of admission + 1.
Number of Hours for Dose Interruptions Up to 24 weeks after first dose of venetoclax 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.
Number of Weeks for Ramping up Venetoclax Dose to 400 mg daily (QD) or maximum dose reached Up to approximately 6 weeks 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.
Number of Hours from Dosing to Blood Draw Baseline (Day 0) Number of hours between laboratory assessments and the first dose of each ramp-up dose for venetoclax
Intravenous (IV) fluid hydration Up to 24 weeks after first dose of venetoclax Type of IV fluid participant was on hydration, rate and duration are assessed.
Percent of Participants with Tumor Burden of Low, Medium, and High Baseline (Day 0) Percent of participants with tumor burden of low, medium, and high.
Other Actions Taken within the First 24 Hours of each Dose Ramp-up Up to approximately 6 weeks Other actions taken within the first 24 hours of each dose ramp-up, for example, prophylaxis treatment
Change from Baseline in Health Care Resource Utilization (HCRU) Up to 24 weeks after first dose of venetoclax HCRU will be evaluated using self-administered questionnaire aimed at measuring the patient's health care resource utilization.
Change in Metabolites Post Dose Up to 24 weeks after first dose of venetoclax Change in metabolites (potassium, creatinine, uric acid, phosphorus, calcium) post dose.
Percentage of Participants with Prophylactic Hospitalization Up to approximately 6 weeks Percentage of participants with prophylactic hospitalization is defined as the percentage of participants who are hospitalized for prophylactic measures.
Reasons for Dose Interruptions Up to 24 weeks after first dose of venetoclax Reasons for dose interruptions.
Change in Creatinine Clearance Up to 24 weeks after first dose of venetoclax Change in creatinine clearance is defined as the change of creatinine clearance from Baseline (Day 0).
Number of Days on Each Dose of Venetoclax Up to 24 weeks after first 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Exposure to Ibrutinib and/or Idelalisib Prior to Baseline Baseline (Day 0) Participants with previous exposure to ibrutinib and/or idelalisib prior to Baseline (Day 0).
Weeks since Last CLL Relapse Baseline (Day 0) Duration of time from most recent CLL relapse and Baseline (Day 0).
Percentage of Participants with Other Mutations Baseline (Day 0) Percentage of participants with other mutations.
Percentage of Participants with Major Co-Morbidities Baseline (Day 0) Percentage of participants with major co-morbidities including medical history/surgery and transplant prior to Baseline (Day 0).
Change from Baseline in Eastern Cooperative Oncology Group Performance Status Up to 24 weeks after first dose of venetoclax Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.
Change from Baseline in QLQ-CLL17 Scores Up to 24 weeks after first dose of venetoclax Change from baseline in Quality of Life Questionnaire - Chronic Lymphocytic Leukemia (QLQ-CLL)17 scores.
Percent of Participants at Each Stage in the Binet Staging System Baseline (Day 0) Percent of participants at each stage in the Binet Staging System for CLL.
Number of Prior Lines of Therapy for CLL Baseline (Day 0) Number of prior lines of therapy for CLL before initiating administration with venetoclax.
Change from Baseline in EORTC QLQ-C30 Scores Up to 24 weeks after first dose of venetoclax Change from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores.
Weeks Since Initiating First Line of Therapy for CLL Baseline (Day 0) Duration of time in weeks from date of first line of therapy administered for CLL to Baseline (Day 0).
Weeks since the Last Line of Therapy (Agent) for CLL Prior to Baseline Baseline (Day 0) Duration of time in weeks since line of therapy (agent) administered for CLL prior to Baseline (Day 0).
Percent of Participants at Each Stage in the Rai Staging System Baseline (Day 0) Percent of participants at each stage in the Rai Staging System for CLL.
Percentage of Participants with Del(17p) Baseline (Day 0) Percentage of participants with the deletion of the short arm of chromosome 17 (Del\[17p\]).
Years to Treatment from Initial Diagnosis of Chronic Lymphocytic Leukemia (CLL) Baseline (Day 0) Years to treatment with venetoclax (Baseline, Day 0) from initial diagnosis of CLL.
Weeks since First CLL Relapse Baseline (Day 0) Duration of time in weeks from diagnosis of CLL to first relapse.
Trial Locations
- Locations (13)
The Moncton Hospital /ID# 166043
🇨🇦Moncton, New Brunswick, Canada
Jack Ady Cancer Centre /ID# 217491
🇨🇦Lethbridge, Alberta, Canada
Jewish General Hospital /ID# 166418
🇨🇦Montreal, Quebec, Canada
University of Calgary /ID# 166416
🇨🇦Calgary, Alberta, Canada
QE II Health Sciences Centre /ID# 213548
🇨🇦Halifax, Nova Scotia, Canada
CISSSBSL -Hopital regional de Rimouski /ID# 201202
🇨🇦Rimouski, Quebec, Canada
Cross Cancer Institute /ID# 166417
🇨🇦Edmonton, Alberta, Canada
CancerCare Manitoba /ID# 170751
🇨🇦Winnipeg, Manitoba, Canada
William Osler Health System /ID# 202049
🇨🇦Brampton, Ontario, Canada
Ottawa Hospital Research Institute /ID# 166041
🇨🇦Ottawa, Ontario, Canada
Kingston Health Sciences Centre /ID# 169252
🇨🇦Kingston, Ontario, Canada
Thunder Bay Regional Research Institute /ID# 204740
🇨🇦Thunder Bay, Ontario, Canada
Health Sciences North /ID# 205817
🇨🇦Sudbury, Ontario, Canada