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Completed

NCT Number: 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

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia Chromosome 17 deletion Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary /ID# 166416, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. Reasons for Dose Interruptions

    Time frame: Up to 24 weeks after first dose of venetoclax

    Reasons for dose interruptions.

  10. 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).

  11. 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.

  12. 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.

  13. 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.

Secondary outcomes

  1. Percentage of Participants with Other Mutations

    Time frame: Baseline (Day 0)

    Percentage of participants with other mutations.

  2. Weeks since Last CLL Relapse

    Time frame: Baseline (Day 0)

    Duration of time from most recent CLL relapse and Baseline (Day 0).

  3. 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).

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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]).

  11. 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.

  12. 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.

  13. 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.

  14. 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).

  15. Weeks since First CLL Relapse

    Time frame: Baseline (Day 0)

    Duration of time in weeks from diagnosis of CLL to first relapse.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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)

Acronym: DEVOTE

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 16, 2017
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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