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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)

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ClinicalTrials.gov Identifier: NCT03310190
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date October 11, 2017
First Posted Date October 16, 2017
Last Update Posted Date January 2, 2020
Actual Study Start Date January 10, 2018
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2019)
  • Duration of Prophylactic Hospitalization [ Time Frame: 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 [ Time Frame: Baseline (Day 0) ]
    Number of hours between laboratory assessments and the first dose of each ramp-up dose for venetoclax
  • Intravenous (IV) fluid hydration [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 24 weeks after first dose of venetoclax ]
    Reasons for dose interruptions.
  • Change in Creatinine Clearance [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: October 11, 2017)
  • Number of Hours on Intravenous (IV) fluid hydration [ Time Frame: Up to 24 weeks ]
    Number of hours a participant was on IV fluid hydration.
  • Number of Hours from Dosing to Blood Draw [ Time Frame: Baseline (Day 0) ]
    Number of hours between laboratory assessments and the first dose of each ramp-up dose for venetoclax
  • Percentage of Participants with Prophylactic Hospitalization [ Time Frame: Up to approximately 6 weeks ]
    Percentage of participants with prophylactic hospitalization is defined as the percentage of participants who are hospitalized for prophylactic measures.
  • Duration of Prophylactic Hospitalization [ Time Frame: Up to approximately 6 weeks ]
    Duration of prophylactic hospitalization is defined as the date of discharge - the date of admission + 1.
  • Number of Days on Each Dose of Venetoclax [ Time Frame: Up to 24 weeks ]
    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.
  • Number of Hours for Dose Interruptions [ Time Frame: Up to 24 weeks ]
    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.
  • Reasons for Dose Interruptions [ Time Frame: Up to 24 weeks ]
    Reasons for dose interruptions.
  • Other Actions Taken within the First 24 Hours of each Dose Ramp-up [ Time Frame: Up to approximately 6 weeks ]
    Other actions taken within the first 24 hours of each dose ramp-up, for example, prophylaxis treatment
  • Number of Weeks for Ramping up Venetoclax Dose to 400 mg daily (QD) [ Time Frame: Up to approximately 6 weeks ]
    Number of weeks for ramping up to Venetoclax 400 mg QD as the duration of the ramping-up period in weeks.
  • Change in Creatinine Clearance [ Time Frame: Up to 24 weeks ]
    Change in creatinine clearance is defined as the change of creatinine clearance from Baseline (Day 0).
  • Percent of Participants with Tumor Burden of Low, Medium, and High [ Time Frame: Baseline (Day 0) ]
    Percent of participants with tumor burden of low, medium, and high.
  • Change from Baseline in Health Care Resource Utilization (HCRU) [ Time Frame: Up to 24 weeks ]
    HCRU will be evaluated using self-administered questionnaire aimed at measuring the patient's health care resource utilization.
  • Change in Metabolites Post Dose [ Time Frame: Up to 24 weeks ]
    Change in metabolites (potassium, creatinine, uric acid, phosphorus, calcium) post dose.
Change History Complete list of historical versions of study NCT03310190 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 9, 2019)
  • Percentage of Participants with Other Mutations [ Time Frame: Baseline (Day 0) ]
    Percentage of participants with other mutations.
  • Weeks since Last CLL Relapse [ Time Frame: Baseline (Day 0) ]
    Duration of time from most recent CLL relapse and Baseline (Day 0).
  • Percentage of Participants with Major Co-Morbidities [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline (Day 0) ]
    Percent of participants at each stage in the Rai Staging System for CLL.
  • Percentage of Participants with Del(17p) [ Time Frame: 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 [ Time Frame: Baseline (Day 0) ]
    Percent of participants at each stage in the Binet Staging System for CLL.
  • Number of Prior Lines of Therapy for CLL [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline (Day 0) ]
    Duration of time in weeks from diagnosis of CLL to first relapse.
Original Secondary Outcome Measures
 (submitted: October 11, 2017)
  • Change from Baseline in Eastern Cooperative Oncology Group Performance Status [ Time Frame: Up to 24 weeks ]
    Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.
  • Change from Baseline in EORTC QLQ-C30 Scores [ Time Frame: Up to 24 weeks ]
    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 QLQ-CLL17 Scores [ Time Frame: Up to 24 weeks ]
    Change from baseline in Quality of Life Questionnaire - Chronic Lymphocytic Leukemia (QLQ-CLL)17 scores.
  • Years to Treatment from Initial Diagnosis of Chronic Lymphocytic Leukemia (CLL) [ Time Frame: Baseline (Day 0) ]
    Years to treatment with venetoclax (Baseline, Day 0) from initial diagnosis of CLL.
  • Number of Prior Lines of Therapy for CLL [ Time Frame: Baseline (Day 0) ]
    Number of prior lines of therapy for CLL before initiating administration with venetoclax.
  • Weeks Since Initiating First Line of Therapy for CLL [ Time Frame: Baseline (Day 0) ]
    Duration of time in weeks from date of first line of therapy administered for CLL to Baseline (Day 0).
  • Weeks since First CLL Relapse [ Time Frame: Baseline (Day 0) ]
    Duration of time in weeks from diagnosis of CLL to first relapse.
  • Weeks since Last CLL Relapse [ Time Frame: Baseline (Day 0) ]
    Duration of time from most recent CLL relapse and Baseline (Day 0).
  • Weeks since the Last Line of Therapy (Agent) for CLL Prior to Baseline [ Time Frame: Baseline (Day 0) ]
    Duration of time in weeks since line of therapy (agent) administered for CLL prior to Baseline (Day 0).
  • Percentage of Participants with Exposure to Ibrutinib and/or Idelalisib Prior to Baseline [ Time Frame: Baseline (Day 0) ]
    Participants with previous exposure to ibrutinib and/or idelalisib prior to Baseline (Day 0).
  • Percentage of Participants with Major Co-Morbidities [ Time Frame: 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 Del(17p) [ Time Frame: Baseline (Day 0) ]
    Percentage of participants with the deletion of the short arm of chromosome 17 (Del[17p]).
  • Percentage of Participants with Other Mutations [ Time Frame: Baseline (Day 0) ]
    Percentage of participants with other mutations.
  • Percent of Participants at Each Stage in the Rai Staging System [ Time Frame: Baseline (Day 0) ]
    Percent of participants at each stage in the Rai Staging System for CLL.
  • Percent of Participants at Each Stage in the Binet Staging System [ Time Frame: Baseline (Day 0) ]
    Percent of participants at each stage in the Binet Staging System for CLL.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy
Condition Chronic Lymphocytic Leukemia
Intervention Not Provided
Study Groups/Cohorts Participants receiving venetoclax
Participants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 9, 2019)
70
Original Estimated Enrollment
 (submitted: October 11, 2017)
50
Estimated Study Completion Date December 15, 2020
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sophie Desjardins +1 514 832 7305 sophie.desjardins@abbvie.com
Contact: Paola Lembo paola.lembo@abbvie.com
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03310190
Other Study ID Numbers P16-489
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party AbbVie
Study Sponsor AbbVie
Collaborators Not Provided
Investigators
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date December 2019