Chronic Lymphocytic LeukemiaNCT03374137
Observational Study to Monitor Safety and Effectiveness of Obinutuzumab in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia
An observational study of Chronic Lymphocytic Leukemia and Follicular Lymphoma, run by Hoffmann-La Roche at 17 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Follicular Lymphoma
- What is being tested?
- obinutuzumab
- Type of treatment
- Injection or infusion
- How many people
- 55 participants
- Where
- 17 sitesSouth Korea
- Study dates
- 9 Mar 2018to 10 Nov 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, 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
Who may be able to join
- Administered obinutuzumab under the approved indications in Korea at investigator's discretion
- Previously untreated with obinutuzumab
Who cannot join
- Out-of locally approved indications, dosage, and administration
- Pregnant women, breastfeeding women
- Hepatic disease
- Participate in other clinical trials
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
South Korea17 sites
Inje University Busan Paik Hospital; Hematology-oncology
Busan, 47392
Pusan National University Hospital
Busan, 602-739
St. Vincent's Hospital
Gyeonggi-do, 16247
Hallym University Sacred Heart Hospital; Department of Hematology
Gyeonggi-do, 431-070
Gachon University Gil Medical Center
Incheon, 21565
Catholic Univ. of Incheon St.Mary's Hospital; Hemato-oncology
Incheon
Kyung Hee University Hospital
Seoul, 02447
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Seoul St Mary's Hospital
Seoul, 06591
ChungAng University Hospital
Seoul, 06973
Borame Medical Center
Seoul, 07061
Yeouido St. Mary's Hospital
Seoul, 07345
Korea University Guro Hospital
Seoul, 08308
Samsung Medical Center
Seoul, 135-710
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 6591
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 220-701
About this study
Official title: Post-Marketing Surveillance of Gazyva in Treatment of Patients With Gazyva in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia Patients
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.
- Conditions
- Chronic Lymphocytic Leukemia, Follicular Lymphoma
- Being tested
- obinutuzumab
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obinutuzumabBiological
Also called Gazyva
Obinutuzumab 1000 mg solution used for infusion according to routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| obinutuzumab | Participants with follicular lymphoma or previously untreated chronic lymphocytic leukemia will be treated with obinutuzumab. Receives: Biological: obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Serious Adverse Event (AE)/Adverse Drug Reaction (ADR)
Measured: from baseline until the end of the participant's observation period (up to approximately 8 years)
Percentage of Participants with Unexpected AE/ADR
Measured: from baseline until end of the participant's observation period (up to approximately 8 years)
Percentage of Participants with Expected ADR
Measured: from baseline until end of the participant's observation period (up to approximately 8 years)
Percentage of Participants with Non-serious ADR
Measured: from baseline until end of the participant's observation period (up to approximately 8 years)
Percentage of Participants with AEs of Special Interest (AESIs)
Measured: from baseline until end of the participant's observation period (up to approximately 8 years)
Secondary outcomes (3)
Overall Response Rate
According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 for CLL or Cheson 2014 criteria for FL
Measured: 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
Measured: 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
Measured: from baseline until end of the participant's observation period (up to approximately 8 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start9 Mar 2018
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374137
- Sponsor's protocol ID
- ML30074
- Status last verified
- Jan 2023
- First submitted
- 12 Dec 2017
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Gazyva in Treatment of Patients With Gazyva in Follicular Lymphoma or Previously Untreated Chronic Lymphocytic Leukemia Patients
- ClinicalTrials.gov ID
- NCT03374137
- Acronym / sponsor ID
- ML30074
- Conditions
- Chronic Lymphocytic Leukemia, Follicular Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obinutuzumab | – | Biological: obinutuzumabParticipants with follicular lymphoma or previously untreated chronic lymphocytic leukemia will be treated with obinutuzumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (2 listed)
- Administered obinutuzumab under the approved indications in Korea at investigator's discretion
- Previously untreated with obinutuzumab
Key exclusion criteria (4 listed)
- Out-of locally approved indications, dosage, and administration
- Pregnant women, breastfeeding women
- Hepatic disease
- Participate in other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| obinutuzumabAlso: GazyvaObinutuzumab 1000 mg solution used for infusion according to routine clinical practice. | Biological | obinutuzumab |
Primary outcome
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)
3 secondary outcomes
Overall Response Rate
Time frame: from baseline until end of the participant's observation period (up to approximately 8 years)
Stable Disease Rate
Time frame: from baseline until end of the participant's observation period (up to approximately 8 years)
Progressive Disease Rate
Time frame: from baseline until end of the participant's observation period (up to approximately 8 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia and Follicular Lymphoma, run by Hoffmann-La Roche at 17 sites in South Korea.
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 4 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 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in South Korea. 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?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2023.