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

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)

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 Overview

• Status: Completed
• Conditions: Chronic Lymphocytic Leukemia

• Study Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary /ID# 166416
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute /ID# 166417
    • Lethbridge, Alberta, Canada, T1J 1W5
      • Jack Ady Cancer Centre /ID# 217491
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba /ID# 170751
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • The Moncton Hospital /ID# 166043
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • QE II Health Sciences Centre /ID# 213548
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • William Osler Health System /ID# 202049
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston Health Sciences Centre /ID# 169252
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Research Institute /ID# 166041
    • Sudbury, Ontario, Canada, P3E 5J1
      • Health Sciences North /ID# 205817
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Thunder Bay Regional Research Institute /ID# 204740
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital /ID# 166418
    • Rimouski, Quebec, Canada, G5L 5T1
      • CISSSBSL -Hopital regional de Rimouski /ID# 201202

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants receiving venetoclax; Participants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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
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)
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
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
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
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
Reasons for Dose Interruptions	Reasons for dose interruptions.	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).	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.	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.	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.	Up to 24 weeks after first dose of venetoclax

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Other Mutations	Percentage of participants with other mutations.	Baseline (Day 0)
Weeks since Last CLL Relapse	Duration of time from most recent CLL relapse and Baseline (Day 0).	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).	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).	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.	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.	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.	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).	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.	Baseline (Day 0)
Percentage of Participants with Del(17p)	Percentage of participants with the deletion of the short arm of chromosome 17 (Del[17p]).	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.	Baseline (Day 0)
Number of Prior Lines of Therapy for CLL	Number of prior lines of therapy for CLL before initiating administration with venetoclax.	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.	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).	Baseline (Day 0)
Weeks since First CLL Relapse	Duration of time in weeks from diagnosis of CLL to first relapse.	Baseline (Day 0)

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; Chronic Lymphocytic Leukemia (CLL); Refractory Chronic Lymphocytic Leukemia; Deletion of the short arm of chromosome 17 (Del[17p]); Relapse Chronic Lymphocytic Leukemia; Chronic Lymphocytic Leukemia with deletion of the short arm of chromosome 17
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: P16-489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No