Study to Describe the Management and the Use of Healthcare Resources in Patients With Chronic Lymphocytic Leukemia (CLL) Initiating Venetoclax in Routine Clinical Practice

Chronic Lymphocytic Leukemia Clinical Trial

— DEVOTE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310190
• Other study ID #: P16-489
• Status: Completed
• Start date: January 10, 2018
• Est. completion date: April 30, 2022

Study information

• Verified date: March 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Locations

Country	Name	City	State
Canada	William Osler Health System /ID# 202049	Brampton	Ontario
Canada	University of Calgary /ID# 166416	Calgary	Alberta
Canada	Cross Cancer Institute /ID# 166417	Edmonton	Alberta
Canada	QE II Health Sciences Centre /ID# 213548	Halifax	Nova Scotia
Canada	Kingston Health Sciences Centre /ID# 169252	Kingston	Ontario
Canada	Jack Ady Cancer Centre /ID# 217491	Lethbridge	Alberta
Canada	The Moncton Hospital /ID# 166043	Moncton	New Brunswick
Canada	Jewish General Hospital /ID# 166418	Montreal	Quebec
Canada	Ottawa Hospital Research Institute /ID# 166041	Ottawa	Ontario
Canada	CISSSBSL -Hopital regional de Rimouski /ID# 201202	Rimouski	Quebec
Canada	Health Sciences North /ID# 205817	Sudbury	Ontario
Canada	Thunder Bay Regional Research Institute /ID# 204740	Thunder Bay	Ontario
Canada	CancerCare Manitoba /ID# 170751	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Prophylactic Hospitalization	Duration of prophylactic hospitalization is defined as the date of discharge - the date of admission + 1.	Up to approximately 6 weeks
Primary	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	Baseline (Day 0)
Primary	Intravenous (IV) fluid hydration	Type of IV fluid participant was on hydration, rate and duration are assessed.	Up to 24 weeks after first dose of venetoclax
Primary	Percent of Participants with Tumor Burden of Low, Medium, and High	Percent of participants with tumor burden of low, medium, and high.	Baseline (Day 0)
Primary	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	Up to approximately 6 weeks
Primary	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.	Up to 24 weeks after first dose of venetoclax
Primary	Change in Metabolites Post Dose	Change in metabolites (potassium, creatinine, uric acid, phosphorus, calcium) post dose.	Up to 24 weeks after first dose of venetoclax
Primary	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.	Up to approximately 6 weeks
Primary	Reasons for Dose Interruptions	Reasons for dose interruptions.	Up to 24 weeks after first dose of venetoclax
Primary	Change in Creatinine Clearance	Change in creatinine clearance is defined as the change of creatinine clearance from Baseline (Day 0).	Up to 24 weeks after first dose of venetoclax
Primary	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.	Up to 24 weeks after first dose of venetoclax
Primary	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.	Up to approximately 6 weeks
Primary	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.	Up to 24 weeks after first dose of venetoclax
Secondary	Percentage of Participants with Other Mutations	Percentage of participants with other mutations.	Baseline (Day 0)
Secondary	Weeks since Last CLL Relapse	Duration of time from most recent CLL relapse and Baseline (Day 0).	Baseline (Day 0)
Secondary	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).	Baseline (Day 0)
Secondary	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).	Baseline (Day 0)
Secondary	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.	Up to 24 weeks after first dose of venetoclax
Secondary	Change from Baseline in Eastern Cooperative Oncology Group Performance Status	Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.	Up to 24 weeks after first dose of venetoclax
Secondary	Change from Baseline in QLQ-CLL17 Scores	Change from baseline in Quality of Life Questionnaire - Chronic Lymphocytic Leukemia (QLQ-CLL)17 scores.	Up to 24 weeks after first dose of venetoclax
Secondary	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).	Baseline (Day 0)
Secondary	Percent of Participants at Each Stage in the Rai Staging System	Percent of participants at each stage in the Rai Staging System for CLL.	Baseline (Day 0)
Secondary	Percentage of Participants with Del(17p)	Percentage of participants with the deletion of the short arm of chromosome 17 (Del[17p]).	Baseline (Day 0)
Secondary	Percent of Participants at Each Stage in the Binet Staging System	Percent of participants at each stage in the Binet Staging System for CLL.	Baseline (Day 0)
Secondary	Number of Prior Lines of Therapy for CLL	Number of prior lines of therapy for CLL before initiating administration with venetoclax.	Baseline (Day 0)
Secondary	Years to Treatment from Initial Diagnosis of Chronic Lymphocytic Leukemia (CLL)	Years to treatment with venetoclax (Baseline, Day 0) from initial diagnosis of CLL.	Baseline (Day 0)
Secondary	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).	Baseline (Day 0)
Secondary	Weeks since First CLL Relapse	Duration of time in weeks from diagnosis of CLL to first relapse.	Baseline (Day 0)

External Links

•   clinical study report synopsis