Non-Hodgkin's LymphomaNCT02199288
Effectiveness, Safety & Nurse Management Study of MabThera SC in Patients With Non-Hodgkin's Lymphoma: Real-Life Setting
An observational study of Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 7 sites in Sweden.
Trial summary
This prospective, open-label, multicenter, observational study will investigate the effectiveness and safety of MabThera SC (rituximab, subcutaneous) induction therapy in patients with non-Hodgkin's lymphoma, following a first initial treatment of MabThera IV (rituximab, intraveneous). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- How many people
- 54 participants
- Where
- 7 sitesSweden
- Study dates
- Aug 2014to Jul 2016
- 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: Patients within label indication for MabThera SC and subject for induction therapy with MabThera SC; patients object for maintenance therapy are excluded
Who may be able to join
- Indication according to the Summary of Product Characteristics (SPC) for MabThera SC formulation:
- As treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy
- As treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with chemotherapy
- At least 4 treatment cycles with MabThera is planned
- Patients >/= 18 years at inclusion
- Patients written informed consent
- Treatment decision to prescribe MabThera SC has been taken by the physician prior to recruitment into the study
Who cannot join
- Contraindications according to SPC for MabThera SC formulation:
- Hypersensitivity for the active substance or murine antibodies, hyaluronidase or any other excipients
- Active and severe infections
- Patients with severe immunsuppression
- Patient included in clinical trials with experimental pharmaceuticals
- Pregnancy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Sweden7 sites
Study site
Eskilstuna, 63188
Study site
Halmstad, 301 85
Study site
Helsingborg, 25187
Study site
Linköping, 581 85
Study site
Luleå, S-971 80
Study site
Örebro, 701 85
Study site
Visby, 62184
About this study
Official title: A NON-INTERVENTIONAL STUDY TO EVALUATE THE EFFECTIVENESS, SAFETY AND NURSE MANAGEMENT DURING INDUCTION TREATMENT WITH MABTHERA S.C. FOLLOWING A FIRST INITIAL MABTHERA I.V. TREATMENT, IN PATIENTS WITH NON-HODGKINS LYMPHOMA IN A REAL-LIFE SETTING
This prospective, open-label, multicenter, observational study will investigate the effectiveness and safety of MabThera SC (rituximab, subcutaneous) induction therapy in patients with non-Hodgkin's lymphoma, following a first initial treatment of MabThera IV (rituximab, intraveneous). Induction treatment period in the study is estimated to be 8 months.
- Conditions
- Non-Hodgkin's Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate using the International Working Group criteria
Measured: 8 months
Secondary outcomes (3)
Incidence of adverse events
Measured: Through to end of study, up to approximately 1 year
Incidence of administration related reactions during induction therapy in patients who have previously received at least one dose of MabThera IV
Measured: Through to end of study, up to approximately 1 year
Incidence of serious adverse events
Measured: Through to end of study, up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies 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
- 54 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
- NCT02199288
- Sponsor's protocol ID
- ML29314
- Status last verified
- Nov 2016
- First submitted
- 18 Jul 2014
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A NON-INTERVENTIONAL STUDY TO EVALUATE THE EFFECTIVENESS, SAFETY AND NURSE MANAGEMENT DURING INDUCTION TREATMENT WITH MABTHERA S.C. FOLLOWING A FIRST INITIAL MABTHERA I.V. TREATMENT, IN PATIENTS WITH NON-HODGKINS LYMPHOMA IN A REAL-LIFE SETTING
- ClinicalTrials.gov ID
- NCT02199288
- Acronym / sponsor ID
- ML29314
- Conditions
- Non-Hodgkin's Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 24 Jul 2014 (estimated)
- 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 prospective, open-label, multicenter, observational study will investigate the effectiveness and safety of MabThera SC (rituximab, subcutaneous) induction therapy in patients with non-Hodgkin's lymphoma, following a first initial treatment of MabThera IV (rituximab, intraveneous). Induction treatment period in the study is estimated to be 8 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients within label indication for MabThera SC and subject for induction therapy with MabThera SC; patients object for maintenance therapy are excluded
Key inclusion criteria (7 listed)
- Indication according to the Summary of Product Characteristics (SPC) for MabThera SC formulation:
- At least 4 treatment cycles with MabThera is planned
- Patients >/= 18 years at inclusion
- Patients written informed consent
- Treatment decision to prescribe MabThera SC has been taken by the physician prior to recruitment into the study
Key exclusion criteria (6 listed)
- Contraindications according to SPC for MabThera SC formulation:
- Patient included in clinical trials with experimental pharmaceuticals
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response rate using the International Working Group criteria
Time frame: 8 months
3 secondary outcomes
Incidence of adverse events
Time frame: Through to end of study, up to approximately 1 year
Incidence of administration related reactions during induction therapy in patients who have previously received at least one dose of MabThera IV
Time frame: Through to end of study, up to approximately 1 year
Incidence of serious adverse events
Time frame: Through to end of study, up to approximately 1 year
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 2 Nov 2016.
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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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 7 sites in Sweden.
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 7 inclusion and 6 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden. 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?
Response rate using the International Working Group criteria (time frame: 8 months). 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 2 Nov 2016.