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

Sponsor

AbbVie (Industry)

Overall Status

Completed

CT.gov ID

NCT03310190

Collaborator

(none)

Enrollment

Locations

51.6

Actual Duration (Months)

7.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia

Study Design

Study Type:

Observational

Actual Enrollment :

93 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Actual Study Start Date :

Jan 10, 2018

Actual Primary Completion Date :

Apr 30, 2022

Actual Study Completion Date :

Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Participants receiving venetoclax Participants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.

Outcome Measures

Primary Outcome Measures

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 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 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 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

Percentage of Participants with Other Mutations [Baseline (Day 0)]
Percentage of participants with other mutations.
Weeks since Last CLL Relapse [Baseline (Day 0)]
Duration of time from most recent CLL relapse and Baseline (Day 0).
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).
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).
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.
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.
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).
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]).
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.
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 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).
Weeks since First CLL Relapse [Baseline (Day 0)]
Duration of time in weeks from diagnosis of CLL to first relapse.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

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