An observational study in Chronic Lymphocytic Leukemia, sponsored by AbbVie. Completed at 13 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by AbbVie · Observational
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Among 51 studies in Leukemia, Lymphocytic, Chronic, B-Cell by AbbVie — 3 open to participants now, 11 under way, 2 of them phase 3. Leukemia, Lymphocytic, Chronic, B-Cell · AbbVie.
Among the 51 studies in Leukemia, Lymphocytic, Chronic, B-Cell by AbbVie, this one is the 6th largest by enrollment of the 12 observational ones that give a count, is one of 2 that started in 2018, is one of 12 observational ones, and was the 31st registered.
2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →3 of the 51 studies in Leukemia, Lymphocytic, Chronic, B-Cell by AbbVie are open now, in 12 countries. Recruiting first, the newest first:
AbbVie · Sites in United States, Australia, France and 6 more countries
Ages 18+
AbbVie · Sites in United States, Australia, Austria and 8 more countries
Ages 18+
AbbVie · Sites in Austria, Germany, Switzerland
Ages 18+
By country, each count listing its studies:
Of the 188 Leukemia, Lymphocytic, Chronic, B-Cell studies recruiting now, 150 (80%) set no upper age limit and 15 (8%) stop at 75 or younger; 17 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
51 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 17 · Phase 3 9
First in 2004; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 93 is below the median of 146 across 215 observational studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Median enrollment 71 across the 39 interventional studies, 91 across the 12 observational. Of the 38 that completed or were terminated, 18 (47%) have results posted.
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AbbVie is the lead sponsor of 976 studies on the registry; 135 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
4 of the studies in Leukemia, Lymphocytic, Chronic, B-Cell by AbbVie that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03844048Phase 3AbbVieAn Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial | 2027-08 |
| NCT04895436AbbVieStudy to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL) | 2026-11 |
| NCT05512390AbbVieA Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL) | 2027-02 |
| NCT06291220AbbVieA Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) | 2027-07 |
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Among the 51 studies in Leukemia, Lymphocytic, Chronic, B-Cell by AbbVie, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A study to assess the real-life management and use of healthcare resources during the initiation of:
Participants with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.
Duration of Prophylactic Hospitalization
Duration of prophylactic hospitalization is defined as the date of discharge - the date of admission + 1.
Time frame: 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
Time frame: Baseline (Day 0)
Intravenous (IV) fluid hydration
Type of IV fluid participant was on hydration, rate and duration are assessed.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 6 weeks
Reasons for Dose Interruptions
Reasons for dose interruptions.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 weeks after first dose of venetoclax
Percentage of Participants with Other Mutations
Percentage of participants with other mutations.
Time frame: Baseline (Day 0)
Weeks since Last CLL Relapse
Duration of time from most recent CLL relapse and Baseline (Day 0).
Time frame: Baseline (Day 0)
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).
Time frame: Baseline (Day 0)
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).
Time frame: Baseline (Day 0)
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.
Time frame: Up to 24 weeks after first dose of venetoclax
Change from Baseline in Eastern Cooperative Oncology Group Performance Status
Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.
Time frame: Up to 24 weeks after first dose of venetoclax
Change from Baseline in QLQ-CLL17 Scores
Change from baseline in Quality of Life Questionnaire - Chronic Lymphocytic Leukemia (QLQ-CLL)17 scores.
Time frame: Up to 24 weeks after first dose of venetoclax
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).
Time frame: Baseline (Day 0)
Percent of Participants at Each Stage in the Rai Staging System
Percent of participants at each stage in the Rai Staging System for CLL.
Time frame: Baseline (Day 0)
Percentage of Participants with Del(17p)
Percentage of participants with the deletion of the short arm of chromosome 17 (Del\[17p\]).
Time frame: Baseline (Day 0)
Percent of Participants at Each Stage in the Binet Staging System
Percent of participants at each stage in the Binet Staging System for CLL.
Time frame: Baseline (Day 0)
Number of Prior Lines of Therapy for CLL
Number of prior lines of therapy for CLL before initiating administration with venetoclax.
Time frame: Baseline (Day 0)
Years to Treatment from Initial Diagnosis of Chronic Lymphocytic Leukemia (CLL)
Years to treatment with venetoclax (Baseline, Day 0) from initial diagnosis of CLL.
Time frame: Baseline (Day 0)
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).
Time frame: Baseline (Day 0)
Weeks since First CLL Relapse
Duration of time in weeks from diagnosis of CLL to first relapse.
Time frame: Baseline (Day 0)
Plan to share: Undecided
Ran from Jan 2018 to primary completion in Apr 2022, 51 months.
Of 34 industry-sponsored observational studies under Leukemia, Lymphocytic, Chronic, B-Cell, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 66. This study's 51 months is close to that.
Counting every sponsor, half of 104 studies reached it within 60 months; a quarter within 32 and three quarters within 176.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Leukemia, Lymphocytic, Chronic, B-Cell →