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 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.

Trial Description

Primary Outcome:

• Duration of Prophylactic Hospitalization
• Number of Hours from Dosing to Blood Draw
• 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) or maximum dose reached
• Number of Days on Each Dose of Venetoclax

• 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