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 |
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Recruitment Status :
Recruiting
First Posted : October 16, 2017
Last Update Posted : July 11, 2019
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Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
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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.
| Condition or disease |
|---|
| Chronic Lymphocytic Leukemia |
| Study Type : | Observational |
| Estimated Enrollment : | 70 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 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Venetoclax
| Group/Cohort |
|---|
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Participants receiving venetoclax
Participants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.
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Primary Outcome Measures :
- 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.
- 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
- Intravenous (IV) fluid hydration [ Time Frame: Up to 24 weeks after first dose of venetoclax ]Type of IV fluid participant was on hydration, rate and duration are assessed.
- 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.
- 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
- Change from Baseline in Health Care Resource Utilization (HCRU) [ Time Frame: Up to 24 weeks after first dose of venetoclax ]HCRU will be evaluated using self-administered questionnaire aimed at measuring the patient's health care resource utilization.
- Change in Metabolites Post Dose [ Time Frame: Up to 24 weeks after first dose of venetoclax ]Change in metabolites (potassium, creatinine, uric acid, phosphorus, calcium) post dose.
- 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.
- Reasons for Dose Interruptions [ Time Frame: Up to 24 weeks after first dose of venetoclax ]Reasons for dose interruptions.
- Change in Creatinine Clearance [ Time Frame: Up to 24 weeks after first dose of venetoclax ]Change in creatinine clearance is defined as the change of creatinine clearance from Baseline (Day 0).
- Number of Hours for Dose Interruptions [ Time Frame: Up to 24 weeks after first dose of venetoclax ]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.
- Number of Weeks for Ramping up Venetoclax Dose to 400 mg daily (QD) or maximum dose reached [ Time Frame: Up to approximately 6 weeks ]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.
- Number of Days on Each Dose of Venetoclax [ Time Frame: Up to 24 weeks after first 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.
Secondary Outcome Measures :
- Percentage of Participants with Other Mutations [ Time Frame: Baseline (Day 0) ]Percentage of participants with other mutations.
- Weeks since Last CLL Relapse [ Time Frame: Baseline (Day 0) ]Duration of time from most recent CLL relapse and Baseline (Day 0).
- 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).
- 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).
- Change from Baseline in EORTC QLQ-C30 Scores [ Time Frame: Up to 24 weeks after first dose of venetoclax ]Change from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores.
- Change from Baseline in Eastern Cooperative Oncology Group Performance Status [ Time Frame: Up to 24 weeks after first dose of venetoclax ]Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.
- Change from Baseline in QLQ-CLL17 Scores [ Time Frame: Up to 24 weeks after first dose of venetoclax ]Change from baseline in Quality of Life Questionnaire - Chronic Lymphocytic Leukemia (QLQ-CLL)17 scores.
- 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).
- 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.
- 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]).
- 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.
- 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.
- 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.
- 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).
- 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 and older (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
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) and has received at least one prior therapy.
Exclusion Criteria:
- 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.
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 | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, New Brunswick | |
| The Moncton Hospital /ID# 166043 | Recruiting |
| Moncton, New Brunswick, Canada, E1C 6Z8 | |
| Saint John Regional Hospital /ID# 202190 | Not yet recruiting |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Nova Scotia | |
| Qe Ii Hsc /Id# 213548 | Not yet recruiting |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| William Osler Health System /ID# 202049 | Recruiting |
| Brampton, Ontario, Canada, L6R 3J7 | |
| Michael Garron Hospital/Toronto East Health Network /ID# 209463 | Not yet recruiting |
| East York, Ontario, Canada, M4C 3E7 | |
| 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 | Recruiting |
| Sudbury, Ontario, Canada, P3N 1H5 | |
| Canada, Quebec | |
| Jewish General Hospital /ID# 166418 | Recruiting |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Cisss Du Bas-Saint-Laurent Hopital Regional de Rimouski /Id# 201202 | Recruiting |
| Rimouski, Quebec, Canada, G5L 5T1 | |
| Canada | |
| CancerCare Manitoba /ID# 170751 | Recruiting |
| Manitoba, Canada, R3E 0V9 | |
| " Thunder Bay Regional Health Sciences Centre, Thunder Bay Regional Health Resea /ID# 204740 | 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 11, 2019 |
| Last Verified: | July 2019 |
| 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:
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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:
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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 |