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Chronic Lymphocytic LeukemiaDEVOTENCT03310190

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

An observational study of Chronic Lymphocytic Leukemia, run by AbbVie at 13 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
How many people
93 participants
Where
13 sitesCanada
Study dates
10 Jan 2018to 30 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Canada13 sites

  • William Osler Health System /ID# 202049

    Brampton, Ontario, L6R 3J7

  • University of Calgary /ID# 166416

    Calgary, Alberta, T2N 4Z6

  • Cross Cancer Institute /ID# 166417

    Edmonton, Alberta, T6G 1Z2

  • Health Sciences North /ID# 205817

    Greater Sudbury, Ontario, P3E 5J1

  • QE II Health Sciences Centre /ID# 213548

    Halifax, Nova Scotia, B3H 1V7

  • Kingston Health Sciences Centre /ID# 169252

    Kingston, Ontario, K7L 2V7

  • Jack Ady Cancer Centre /ID# 217491

    Lethbridge, Alberta, T1J 1W5

  • The Moncton Hospital /ID# 166043

    Moncton, New Brunswick, E1C 6Z8

  • Jewish General Hospital /ID# 166418

    Montreal, Quebec, H3T 1E2

  • Ottawa Hospital Research Institute /ID# 166041

    Ottawa, Ontario, K1H 8L6

  • CISSSBSL -Hopital regional de Rimouski /ID# 201202

    Rimouski, Quebec, G5L 5T1

  • Thunder Bay Regional Research Institute /ID# 204740

    Thunder Bay, Ontario, P7B 6V4

  • CancerCare Manitoba /ID# 170751

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

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)

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.
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
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Chromosome 17 deletion, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03310190
Study groupRoleWhat they receive
Participants receiving venetoclaxParticipants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of Prophylactic Hospitalization

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

    Measured: Up to approximately 6 weeks

  2. 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

    Measured: Baseline (Day 0)

  3. Intravenous (IV) fluid hydration

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

    Measured: Up to 24 weeks after first dose of venetoclax

  4. Percent of Participants with Tumor Burden of Low, Medium, and High

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

    Measured: Baseline (Day 0)

  5. 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

    Measured: Up to approximately 6 weeks

  6. 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.

    Measured: Up to 24 weeks after first dose of venetoclax

  7. Change in Metabolites Post Dose

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

    Measured: Up to 24 weeks after first dose of venetoclax

  8. 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.

    Measured: Up to approximately 6 weeks

  9. Reasons for Dose Interruptions

    Reasons for dose interruptions.

    Measured: Up to 24 weeks after first dose of venetoclax

  10. Change in Creatinine Clearance

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

    Measured: Up to 24 weeks after first dose of venetoclax

  11. 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.

    Measured: Up to 24 weeks after first dose of venetoclax

  12. 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.

    Measured: Up to approximately 6 weeks

  13. 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.

    Measured: Up to 24 weeks after first dose of venetoclax

Secondary outcomes (15)

  1. Percentage of Participants with Other Mutations

    Percentage of participants with other mutations.

    Measured: Baseline (Day 0)

  2. Weeks since Last CLL Relapse

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

    Measured: Baseline (Day 0)

  3. Percentage of Participants with Major Co-Morbidities

    Percentage of participants with major co-morbidities including medical history/surgery and transplant prior to Baseline (Day 0).

    Measured: Baseline (Day 0)

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

    Participants with previous exposure to ibrutinib and/or idelalisib prior to Baseline (Day 0).

    Measured: Baseline (Day 0)

  5. Change from Baseline in EORTC QLQ-C30 Scores

    Change from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores.

    Measured: Up to 24 weeks after first dose of venetoclax

  6. Change from Baseline in Eastern Cooperative Oncology Group Performance Status

    Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.

    Measured: Up to 24 weeks after first dose of venetoclax

  7. Change from Baseline in QLQ-CLL17 Scores

    Change from baseline in Quality of Life Questionnaire - Chronic Lymphocytic Leukemia (QLQ-CLL)17 scores.

    Measured: Up to 24 weeks after first dose of venetoclax

  8. Weeks Since Initiating First Line of Therapy for CLL

    Duration of time in weeks from date of first line of therapy administered for CLL to Baseline (Day 0).

    Measured: Baseline (Day 0)

  9. Percent of Participants at Each Stage in the Rai Staging System

    Percent of participants at each stage in the Rai Staging System for CLL.

    Measured: Baseline (Day 0)

  10. Percentage of Participants with Del(17p)

    Percentage of participants with the deletion of the short arm of chromosome 17 (Del[17p]).

    Measured: Baseline (Day 0)

  11. Percent of Participants at Each Stage in the Binet Staging System

    Percent of participants at each stage in the Binet Staging System for CLL.

    Measured: Baseline (Day 0)

  12. Number of Prior Lines of Therapy for CLL

    Number of prior lines of therapy for CLL before initiating administration with venetoclax.

    Measured: Baseline (Day 0)

  13. Years to Treatment from Initial Diagnosis of Chronic Lymphocytic Leukemia (CLL)

    Years to treatment with venetoclax (Baseline, Day 0) from initial diagnosis of CLL.

    Measured: Baseline (Day 0)

  14. Weeks since the Last Line of Therapy (Agent) for CLL Prior to Baseline

    Duration of time in weeks since line of therapy (agent) administered for CLL prior to Baseline (Day 0).

    Measured: Baseline (Day 0)

  15. Weeks since First CLL Relapse

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

    Measured: Baseline (Day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2017
  2. Study start10 Jan 2018
  3. Primary completion30 Apr 2022
  4. Study completion30 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03310190
Sponsor's protocol ID
P16-489
Acronym
DEVOTE
Status last verified
Mar 2023
First submitted
11 Oct 2017
Last updated
30 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Lymphocytic Leukemia, run by AbbVie at 13 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Prophylactic Hospitalization (time frame: Up to approximately 6 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03310190.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.

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