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

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ClinicalTrials.gov Identifier: NCT03310190
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief 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.

Condition or disease
Chronic Lymphocytic Leukemia (CLL)

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 15, 2020


Group/Cohort
Participants receiving venetoclax
Participants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.



Primary Outcome Measures :
  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. Number of Hours on Intravenous (IV) fluid hydration [ Time Frame: Up to 24 weeks ]
    Number of hours a participant was on IV fluid hydration.

  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 ]
    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 ]
    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 ]
    Reasons for dose interruptions.

  10. Change in Creatinine Clearance [ Time Frame: Up to 24 weeks ]
    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 ]
    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) [ Time Frame: Up to approximately 6 weeks ]
    Number of weeks for ramping up to Venetoclax 400 mg QD 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 ]
    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 Outcome Measures :
  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 ]
    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 ]
    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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy or participants with CLL without del(17p) who have received at least one prior therapy and for whom there are no other available treatment options
Criteria

Inclusion Criteria:

  • Patient's physician prescribed venetoclax as per product monograph independent of the patient participation in this study.
  • Has chronic lymphocytic leukemia (CLL) with deletion of the short arm of chromosome (17del[17p]) who have received at least 1 prior therapy, or CLL without del(17p) who have received at least one prior therapy and for whom there are no other available treatment options.

Exclusion Criteria:

  • Currently participating in an interventional study.
  • Using strong CYP3A inhibitors.
  • 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.
  • Is pregnant or not using appropriate means of contraception.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310190


Contacts
Contact: Sophie Desjardins +1 514 832 7305 sophie.desjardins@abbvie.com
Contact: Paola Lembo paola.lembo@abbvie.com

Locations
Canada, Alberta
University of Calgary /ID# 166416 Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Cross Cancer Institute /ID# 166417 Not yet recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, New Brunswick
The Moncton Hospital /ID# 166043 Not yet recruiting
Moncton, New Brunswick, Canada, E1C 6Z8
Saint John Regional Hospital /ID# 202190 Not yet recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Ontario
William Osler Health System /ID# 202049 Not yet recruiting
Brampton, Ontario, Canada, L6R 3J7
Kingston Health Sciences Centr /ID# 169252 Recruiting
Kingston, Ontario, Canada, K7L 2V7
The Ottawa Hospital Research /ID# 166041 Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Health Sciences North /ID# 205817 Not yet recruiting
Sudbury, Ontario, Canada, P3N 1H5
Canada, Quebec
Jewish General Hospital /ID# 166418 Not yet recruiting
Montreal, Quebec, Canada, H3T 1E2
Cisss Du Bas-Saint-Laurent Hopital Regional de Rimouski /Id# 201202 Not yet recruiting
Rimouski, Quebec, Canada, G5L 5T1
Canada
CancerCare Manitoba /ID# 170751 Recruiting
Manitoba, Canada, R3E 0V9
Thunder Bay Regional Health Re /ID# 204740 Not yet recruiting
Thunder Bay, Canada, P7B 6V4
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03310190     History of Changes
Other Study ID Numbers: P16-489
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Venetoclax
Antineoplastic Agents