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

NCT03310190 | Completed

• 1 other identifier: P16-489
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 13

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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia (CLL); Deletion of the short arm of chromosome 17 (Del[17p]); Relapse Chronic Lymphocytic Leukemia; Refractory Chronic Lymphocytic Leukemia; Chronic Lymphocytic Leukemia with deletion of the short arm of chromosome 17; Cancer

Outcome Measures

Primary Outcomes (13)

• Duration of Prophylactic Hospitalization

  Duration of prophylactic hospitalization is defined as the date of discharge - the date of admission + 1.

  Up to approximately 6 weeks

• Number of Hours from Dosing to Blood Draw

  Number of hours between laboratory assessments and the first dose of each ramp-up dose for venetoclax

  Baseline (Day 0)

• Intravenous (IV) fluid hydration

  Type of IV fluid participant was on hydration, rate and duration are assessed.

  Up to 24 weeks after first dose of venetoclax

• Percent of Participants with Tumor Burden of Low, Medium, and High

  Percent of participants with tumor burden of low, medium, and high.

  Baseline (Day 0)

• Other Actions Taken within the First 24 Hours of each Dose Ramp-up

  Other actions taken within the first 24 hours of each dose ramp-up, for example, prophylaxis treatment

  Up to approximately 6 weeks

• Change from Baseline in Health Care Resource Utilization (HCRU)

  HCRU will be evaluated using self-administered questionnaire aimed at measuring the patient's health care resource utilization.

  Up to 24 weeks after first dose of venetoclax

• Change in Metabolites Post Dose

  Change in metabolites (potassium, creatinine, uric acid, phosphorus, calcium) post dose.

  Up to 24 weeks after first dose of venetoclax

• Percentage of Participants with Prophylactic Hospitalization

  Percentage of participants with prophylactic hospitalization is defined as the percentage of participants who are hospitalized for prophylactic measures.

  Up to approximately 6 weeks

• Reasons for Dose Interruptions

  Reasons for dose interruptions.

  Up to 24 weeks after first dose of venetoclax

• Change in Creatinine Clearance

  Change in creatinine clearance is defined as the change of creatinine clearance from Baseline (Day 0).

  Up to 24 weeks after first dose of venetoclax

• Number of Hours for Dose Interruptions

  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.

  Up to 24 weeks after first dose of venetoclax

• Number of Weeks for Ramping up Venetoclax Dose to 400 mg daily (QD) or maximum dose reached

  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.

  Up to approximately 6 weeks

• Number of Days on Each 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.

  Up to 24 weeks after first dose of venetoclax

Secondary Outcomes (15)

• Percentage of Participants with Other Mutations

  Baseline (Day 0)

• Weeks since Last CLL Relapse

  Baseline (Day 0)

• Percentage of Participants with Major Co-Morbidities

  Baseline (Day 0)

• Percentage of Participants with Exposure to Ibrutinib and/or Idelalisib Prior to Baseline

  Baseline (Day 0)

• Change from Baseline in EORTC QLQ-C30 Scores

  Up to 24 weeks after first dose of venetoclax

Study Arms (1)

Participants receiving venetoclax

Participants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (13)

University of Calgary /ID# 166416

Calgary, Alberta, T2N 4Z6, Canada

Location

Cross Cancer Institute /ID# 166417

Edmonton, Alberta, T6G 1Z2, Canada

Location

Jack Ady Cancer Centre /ID# 217491

Lethbridge, Alberta, T1J 1W5, Canada

Location

CancerCare Manitoba /ID# 170751

Winnipeg, Manitoba, R3E 0V9, Canada

Location

The Moncton Hospital /ID# 166043

Moncton, New Brunswick, E1C 6Z8, Canada

Location

QE II Health Sciences Centre /ID# 213548

Halifax, Nova Scotia, B3H 1V7, Canada

Location

William Osler Health System /ID# 202049

Brampton, Ontario, L6R 3J7, Canada

Location

Health Sciences North /ID# 205817

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Kingston Health Sciences Centre /ID# 169252

Kingston, Ontario, K7L 2V7, Canada

Location

Ottawa Hospital Research Institute /ID# 166041

Ottawa, Ontario, K1H 8L6, Canada

Location

Thunder Bay Regional Research Institute /ID# 204740

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Jewish General Hospital /ID# 166418

Montreal, Quebec, H3T 1E2, Canada

Location

CISSSBSL -Hopital regional de Rimouski /ID# 201202

Rimouski, Quebec, G5L 5T1, Canada

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Chromosome 17 deletion; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 16, 2017
• Study Start: January 10, 2018
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: March 30, 2023

Record last verified: 2023-03

Locations

CA (13)