An observational study in Chronic Lymphocytic Leukemia and Follicular Lymphoma, sponsored by Hoffmann-La Roche. Completed at 17 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-12.
Sponsored by Hoffmann-La Roche · Observational
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Among 48 studies in Leukemia, Lymphocytic, Chronic, B-Cell by Hoffmann-La Roche — 1 open to participants now, 2 under way, none of them phase 3. Leukemia, Lymphocytic, Chronic, B-Cell · Hoffmann-La Roche.
Among the 48 studies in Leukemia, Lymphocytic, Chronic, B-Cell by Hoffmann-La Roche, this one is the 8th largest by enrollment of the 12 observational ones that give a count, is the only one that started in 2018, is one of 12 observational ones, and was the 45th 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 →1 of the 48 studies in Leukemia, Lymphocytic, Chronic, B-Cell by Hoffmann-La Roche is open now, in 10 countries. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in United States, Australia, China and 7 more countries
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.
48 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 10 · Phase 2 15 · Phase 3 10 · Phase 4 3
First in 2003; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 55 is below the median of 146 across 215 observational studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Median enrollment 99 across the 36 interventional studies, 80 across the 12 observational. Of the 46 that completed or were terminated, 28 (61%) have results posted.
This tab as a report to print or save as PDF → With an account.
Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 48 studies in Leukemia, Lymphocytic, Chronic, B-Cell by Hoffmann-La Roche, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study aims to collect clinical data, mainly focused on safety, in the local target population as per the requirement of Korea Ministry of Food and Drug Safety for market authorization. The study population comprises patients with approved local indications chronic lymphocytic leukemia (CLL) and/or follicular lymphoma (FL) in routine clinical practice after launch.
Participants, who are going to receive obinutuzumab for one or more administrations according to medical opinions of the investigator in charge of surveillance, will be registered for this surveillance and treated with obinutuzumab under the approval conditions of the product in Korea
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Exclusion Criteria:
Participants with follicular lymphoma or previously untreated chronic lymphocytic leukemia will be treated with obinutuzumab.
Biological: obinutuzumab
Obinutuzumab 1000 mg solution used for infusion according to routine clinical practice.
Also known as: Gazyva
Percentage of Participants with Serious Adverse Event (AE)/Adverse Drug Reaction (ADR)
Time frame: from baseline until the end of the participant's observation period (up to approximately 8 years)
Percentage of Participants with Unexpected AE/ADR
Time frame: from baseline until end of the participant's observation period (up to approximately 8 years)
Percentage of Participants with Expected ADR
Time frame: from baseline until end of the participant's observation period (up to approximately 8 years)
Percentage of Participants with Non-serious ADR
Time frame: from baseline until end of the participant's observation period (up to approximately 8 years)
Percentage of Participants with AEs of Special Interest (AESIs)
Time frame: from baseline until end of the participant's observation period (up to approximately 8 years)
Overall Response Rate
According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 for CLL or Cheson 2014 criteria for FL
Time frame: from baseline until end of the participant's observation period (up to approximately 8 years)
Stable Disease Rate
According to IWCLL 2008 for CLL or Cheson 2014 criteria for FL
Time frame: from baseline until end of the participant's observation period (up to approximately 8 years)
Progressive Disease Rate
According to IWCLL 2008 for CLL or Cheson 2014 criteria for FL
Time frame: from baseline until end of the participant's observation period (up to approximately 8 years)
Ran from Mar 2018 to primary completion in Nov 2022, 56 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 56 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 Jan 2023. You cannot join it, but the record below documents what was studied.
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Leukemia, Lymphocytic, Chronic, B-Cell →