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)

Summary:

A study to assess the real-life management and use of healthcare resources during the initiation of venetoclax in participants with chronic lymphocytic leukemia (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.

Trial Description

Primary Outcome:

  • Duration of Prophylactic Hospitalization
  • Number of Hours from Dosing to Blood Draw
  • Number of Hours on Intravenous (IV) fluid hydration
  • Percent of Participants with Tumour Burden of Low, Medium, and High
  • Other Actions Taken within the First 24 Hours of each Dose Ramp-up
  • Change from Baseline in Health Care Resource Utilization (HCRU)
  • Change in Metabolites Post Dose
  • Percentage of Participants with Prophylactic Hospitalization
  • Reasons for Dose Interruptions
  • Change in Creatinine Clearance
  • Number of Hours for Dose Interruptions
  • Number of Weeks for Ramping up Venetoclax Dose to 400 mg daily (QD)
  • Number of Days on Each Dose of Venetoclax
Secondary Outcome:
  • Percentage of Participants with Other Mutations
  • Weeks since Last CLL Relapse
  • Percentage of Participants with Major Co-Morbidities
  • Percentage of Participants with Exposure to Ibrutinib and/or Idelalisib Prior to Baseline
  • Change from Baseline in EORTC QLQ-C30 Scores
  • Change from Baseline in Eastern Cooperative Oncology Group Performance Status
  • Change from Baseline in QLQ-CLL17 Scores
  • Weeks Since Initiating First Line of Therapy for CLL
  • Percent of Participants at Each Stage in the Rai Staging System
  • Percentage of Participants with Del(17p)
  • Percent of Participants at Each Stage in the Binet Staging System
  • Number of Prior Lines of Therapy for CLL
  • Years to Treatment from Initial Diagnosis of Chronic Lymphocytic Leukemia (CLL)
  • Weeks since the Last Line of Therapy (Agent) for CLL Prior to Baseline
  • Weeks since First CLL Relapse

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society