Clinical trial NCT03310190: Study to Describe the Management and the Use of Healthcare Resources in Patients With Chronic Lymphocytic Leukemia (CLL) Initiating Venetoclax in Routine Clinical Practice
Official title: Post-Marketing Observational Study (PMOS) to Describe the Management and the Use of Healthcare Resources in Patients With Chronic Lymphocytic Leukemia (CLL) Initiating Venetoclax in Routine Clinical Practice (DEVOTE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia (CLL)
Deletion of the short arm of chromosome 17 (Del[17p])
Relapse Chronic Lymphocytic Leukemia
Refractory Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia with deletion of the short arm of chromosome 17
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-10-16
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Duration of Prophylactic Hospitalization
timeFrame: Up to approximately 6 weeks
measure: Number of Hours from Dosing to Blood Draw
timeFrame: Baseline (Day 0)
measure: Intravenous (IV) fluid hydration
timeFrame: Up to 24 weeks after first dose of venetoclax
measure: Percent of Participants with Tumor Burden of Low, Medium, and High
timeFrame: Baseline (Day 0)
measure: Other Actions Taken within the First 24 Hours of each Dose Ramp-up
timeFrame: Up to approximately 6 weeks
measure: Change from Baseline in Health Care Resource Utilization (HCRU)
timeFrame: Up to 24 weeks after first dose of venetoclax
measure: Change in Metabolites Post Dose
timeFrame: Up to 24 weeks after first dose of venetoclax
measure: Percentage of Participants with Prophylactic Hospitalization
timeFrame: Up to approximately 6 weeks
measure: Reasons for Dose Interruptions
timeFrame: Up to 24 weeks after first dose of venetoclax
measure: Change in Creatinine Clearance
timeFrame: Up to 24 weeks after first dose of venetoclax
measure: Number of Hours for Dose Interruptions
timeFrame: Up to 24 weeks after first dose of venetoclax
measure: Number of Weeks for Ramping up Venetoclax Dose to 400 mg daily (QD) or maximum dose reached
timeFrame: Up to approximately 6 weeks
measure: Number of Days on Each Dose of Venetoclax
timeFrame: Up to 24 weeks after first dose of venetoclax
Secondary outcomes:
measure: Percentage of Participants with Other Mutations
timeFrame: Baseline (Day 0)
measure: Weeks since Last CLL Relapse
timeFrame: Baseline (Day 0)
measure: Percentage of Participants with Major Co-Morbidities
timeFrame: Baseline (Day 0)
measure: Percentage of Participants with Exposure to Ibrutinib and/or Idelalisib Prior to Baseline
timeFrame: Baseline (Day 0)
measure: Change from Baseline in EORTC QLQ-C30 Scores
timeFrame: Up to 24 weeks after first dose of venetoclax
measure: Change from Baseline in Eastern Cooperative Oncology Group Performance Status
timeFrame: Up to 24 weeks after first dose of venetoclax
measure: Change from Baseline in QLQ-CLL17 Scores
timeFrame: Up to 24 weeks after first dose of venetoclax
measure: Weeks Since Initiating First Line of Therapy for CLL
timeFrame: Baseline (Day 0)
measure: Percent of Participants at Each Stage in the Rai Staging System
timeFrame: Baseline (Day 0)
measure: Percentage of Participants with Del(17p)
timeFrame: Baseline (Day 0)
measure: Percent of Participants at Each Stage in the Binet Staging System
timeFrame: Baseline (Day 0)
measure: Number of Prior Lines of Therapy for CLL
timeFrame: Baseline (Day 0)
measure: Years to Treatment from Initial Diagnosis of Chronic Lymphocytic Leukemia (CLL)
timeFrame: Baseline (Day 0)
measure: Weeks since the Last Line of Therapy (Agent) for CLL Prior to Baseline
timeFrame: Baseline (Day 0)
measure: Weeks since First CLL Relapse
timeFrame: Baseline (Day 0)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary /ID# 166416
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute /ID# 166417
state: Alberta
city: Lethbridge
country: Canada
facility: Jack Ady Cancer Centre /ID# 217491
state: Alberta
city: Winnipeg
country: Canada
facility: CancerCare Manitoba /ID# 170751
state: Manitoba
city: Moncton
country: Canada
facility: The Moncton Hospital /ID# 166043
state: New Brunswick
city: Halifax
country: Canada
facility: QE II Health Sciences Centre /ID# 213548
state: Nova Scotia
city: Brampton
country: Canada
facility: William Osler Health System /ID# 202049
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre /ID# 169252
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute /ID# 166041
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North /ID# 205817
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Research Institute /ID# 204740
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital /ID# 166418
state: Quebec
city: Rimouski
country: Canada
facility: CISSSBSL -Hopital regional de Rimouski /ID# 201202
state: Quebec
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: