Lymphoma, Non-HodgkinNCT03289182
An Observational Study of MabThera Subcutaneous (SC) Safety in Participants With Non-Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL)
An observational study of Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, Chronic, B-Cell, run by Hoffmann-La Roche at 25 sites in South Korea.
Trial summary
This is a prospective, multicenter, non-interventional study to test the safety and effectiveness of MabThera administered subcutaneously in participants with NHL or CLL. The length of study is expected to be 6 years. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
- What is being tested?
- MabThera
- Type of treatment
- Injection or infusion
- How many people
- 701 participants
- Where
- 25 sitesSouth Korea
- Study dates
- 15 Sep 2017to 27 Oct 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants receiving treatment for NHL or CLL with MabThera SC under observation according to standard of care and in line with the current local labelling in Korea.
Who may be able to join
- Participants administered with MabThera subcutaneously within the approved indication in Korea
- Participants previously untreated with MabThera subcutaneously
- Inclusion Criteria for NHL participants for MabThera subcutaneously 1400mg:
- Relapsed or chemoresistant follicular lymphoma (FL) (B, C, and D type by international working formulation classification of B-cell NHL) participants
- Previously untreated FL participants in combination with chemotherapy
- Participants who are treated with maintenance therapy after the treatment of FL participants responding to induction therapy.
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- Cluster of differentiation 20-positive, diffuse large B-cell NHL participants in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone (8 cycles) chemotherapy
- Inclusion Criteria for CLL participants for MabThera subcutaneously 1600mg:
- Previously untreated or relapsed/refractory CLL participants in combination with chemotherapy
Who cannot join
- Pregnant or breastfeeding women
- Participants who are out of locally approved indications, dosage, and administration including medication error
- Contraindication in use by locally approved indications, dosage, and administration
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
South Korea25 sites
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, 420-767
Inje University Busan Paik Hospital
Busan, 47392
Pusan National University Hospital
Busan, 49241
Keimyung University Dongsan Medical Center
Daegu, 41931
Yeungnam University Medical Center
Daegu, 42415
Daegu Catholic University Medical Center; Hematology
Daegu
Chungnam National University Hospital
Daejeon, 35015
Korea University Ansan Hospital
Gyeonggi-do, 15355
St. Vincent's Hospital
Gyeonggi-do, 16247
Hallym University Sacred Heart Hospital; Department of Hematology
Gyeonggi-do, 431-070
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612
Gachon University Gil Medical Center
Incheon, 21565
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128
Inje University, Sanggye-Paik Hospital
Seoul, 01757
Korea University Anam Hospital
Seoul, 02841
Kangbuk Samsung Hospital
Seoul, 03181
Ewha Womans University Mokdong Hospital
Seoul, 07985
Seoul National University Hospital; Department of Oncology
Seoul, 110-744
Severance Hospital, Yonsei University Health System; Oncology
Seoul, 120-752
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, 135-710
St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine
Seoul, 137-701
Korea Cancer Center Hospital; Surgery
Seoul, 139-709
Korea University Guro Hospital; Department of Hematology & Oncology
Seoul, 152-703
SMG-SNU Boramae Medical Center
Seoul, 156-707
Ulsan University Hosiptal
Ulsan, 44033
About this study
Official title: Post-Marketing Surveillance of MabThera Subcutaneous in Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
This is a prospective, multicenter, non-interventional study to test the safety and effectiveness of MabThera administered subcutaneously in participants with NHL or CLL. The length of study is expected to be 6 years.
- Being tested
- MabThera
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MabTheraDrug
Participants will be administered MabThera 1400 mg (NHL) or 1600 mg (CLL) at the discretion of the physician in accordance with local clinical practice and local labeling.
| Study group | Role | What they receive |
|---|---|---|
| MabThera | Participants with NHL will be administered 1400 milligrams (mg) and those with with CLL will be administered 1600 mg MabThera subcutaneously at the discretion of the physician in accordance with local clinical practice and local labeling, and will be observed for 6 years. Receives: Drug: MabThera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events
Measured: Baseline up to Year 6
Secondary outcomes (2)
Percentage of Participants with Overall Response as Assessed by the Investigator Using the Cheson 2014 Criteria for NHL
Measured: Baseline up to Year 6
Percentage of Participants with Overall Response as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria
Measured: Baseline up to Year 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start15 Sep 2017
- Primary completion27 Oct 2020
- Study completion27 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies 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
- 701 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289182
- Sponsor's protocol ID
- ML39600
- Status last verified
- Jan 2021
- First submitted
- 18 Sep 2017
- Last updated
- 11 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of MabThera Subcutaneous in Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT03289182
- Acronym / sponsor ID
- ML39600
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 701 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 27 Oct 2020 (actual)
- Study completion
- 27 Oct 2020 (actual)
- First posted
- 20 Sep 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 is a prospective, multicenter, non-interventional study to test the safety and effectiveness of MabThera administered subcutaneously in participants with NHL or CLL. The length of study is expected to be 6 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MabThera | – | Drug: MabTheraParticipants with NHL will be administered 1400 milligrams (mg) and those with with CLL will be administered 1600 mg MabThera subcutaneously at the discretion of the physician in accordance with local clinical practice and local labeling, and will be observed for 6 years. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants receiving treatment for NHL or CLL with MabThera SC under observation according to standard of care and in line with the current local labelling in Korea.
Key inclusion criteria (9 listed)
- Participants administered with MabThera subcutaneously within the approved indication in Korea
- Participants previously untreated with MabThera subcutaneously
- Relapsed or chemoresistant follicular lymphoma (FL) (B, C, and D type by international working formulation classification of B-cell NHL) participants
- Previously untreated FL participants in combination with chemotherapy
- Participants who are treated with maintenance therapy after the treatment of FL participants responding to induction therapy.
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding women
- Participants who are out of locally approved indications, dosage, and administration including medication error
- Contraindication in use by locally approved indications, dosage, and administration
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 |
|---|---|---|
| MabTheraParticipants will be administered MabThera 1400 mg (NHL) or 1600 mg (CLL) at the discretion of the physician in accordance with local clinical practice and local labeling. | Drug | MabThera |
Primary outcome
Percentage of Participants with Adverse Events
Time frame: Baseline up to Year 6
2 secondary outcomes
Percentage of Participants with Overall Response as Assessed by the Investigator Using the Cheson 2014 Criteria for NHL
Time frame: Baseline up to Year 6
Percentage of Participants with Overall Response as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria
Time frame: Baseline up to Year 6
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 11 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, Chronic, B-Cell, run by Hoffmann-La Roche at 25 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 9 inclusion and 3 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 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 Adverse Events (time frame: Baseline up to Year 6). 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 11 Jan 2021.