Lymphocytic Leukemia, ChronicNCT01072240
An Observational Study on Infusion-related Adverse Events at Administration of MabThera (Rituximab) in Patients With Chronic Lymphocytic Leukemia
An observational study of Lymphocytic Leukemia, Chronic, run by Hoffmann-La Roche at 18 sites in Sweden.
Trial summary
This observational study will monitor and register infusion-related adverse events and their handling in patients with chronic lymphocytic leukemia on treatment with MabThera (rituximab). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphocytic Leukemia, Chronic
- What is being tested?
- rituximab [Mabthera/Rituxan]
- How many people
- 92 participants
- Where
- 18 sitesSweden
- Study dates
- Sep 2009to Jun 2011
- 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: CLL patients receiving standard of care rituximab infusions at haematological or medical clinics
Who may be able to join
- adult patients, >/= 18 years of age
- chronic lymphocytic leukemia treated with rituximab (MabThera)
- rituximab (MabThera) dosage 375 mg/m2 in cycle 1, 500 mg/m2 in subsequent cycles
- informed consent to data collection
Who cannot join
- participation in an interventional clinical study
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Sweden18 sites
Study site
Gävle, 80187
Study site
Gothenburg, SE-41 343
Study site
Huddinge, 14186
Study site
Jönköping, 551_85
Study site
Kalmar, 39185
Study site
Karlstad, 65185
Study site
Kristianstad, 29185
Study site
Lidköping, S-53131
Study site
Linköping, 581 85
Study site
Luleå, S-971 80
Study site
Mora, S-79285
Study site
Norrköping, 60182
Study site
Oskarshamn, 57251
Study site
Stockholm, 17176
Study site
Sundsvall, 85186
Study site
Umeå, 901 85
Study site
Västervik, 59381
Study site
Visby, 62184
About this study
Official title: An Observational Registration Study of Infusion-related Adverse Events at Administration of Mabthera (Rituximab) in the Treatment of Chronic Lymphocytic Leukemia.
This observational study will monitor and register infusion-related adverse events and their handling in patients with chronic lymphocytic leukemia on treatment with MabThera (rituximab). Data will be collected from patients receiving intravenous MabThera at a dose of 375mg/m2 in cycle 1 and 500mg/m2 in subsequent cycles at each treatment visit for up to 6 months. Target sample size is 100 patients.
- Conditions
- Lymphocytic Leukemia, Chronic
- Being tested
- rituximab [Mabthera/Rituxan]
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximab [Mabthera/Rituxan]Drug
As prescribed by physician
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described Receives: Drug: rituximab [Mabthera/Rituxan] |
What is being measured
The primary outcome is the main question the study is designed to answer.
infusion-related adverse events
Measured: data collection every 4-6 weeks for up to 6 months for each patient
Secondary outcomes (1)
usage and applicability of 90-minute iv infusion in patients with CLL
Measured: data collection every 4-6 weeks for up to 6 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startSep 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphocytic Leukemia, ChronicStudies 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
- 92 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
- NCT01072240
- Sponsor's protocol ID
- ML22754
- Status last verified
- Oct 2016
- First submitted
- 8 Feb 2010
- Last updated
- 1 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Registration Study of Infusion-related Adverse Events at Administration of Mabthera (Rituximab) in the Treatment of Chronic Lymphocytic Leukemia.
- ClinicalTrials.gov ID
- NCT01072240
- Acronym / sponsor ID
- ML22754
- Conditions
- Lymphocytic Leukemia, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Feb 2010 (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 observational study will monitor and register infusion-related adverse events and their handling in patients with chronic lymphocytic leukemia on treatment with MabThera (rituximab). Data will be collected from patients receiving intravenous MabThera at a dose of 375mg/m2 in cycle 1 and 500mg/m2 in subsequent cycles at each treatment visit for up to 6 months. Target sample size is 100 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Drug: rituximab [Mabthera/Rituxan] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CLL patients receiving standard of care rituximab infusions at haematological or medical clinics
Key inclusion criteria (4 listed)
- adult patients, >/= 18 years of age
- chronic lymphocytic leukemia treated with rituximab (MabThera)
- rituximab (MabThera) dosage 375 mg/m2 in cycle 1, 500 mg/m2 in subsequent cycles
- informed consent to data collection
Key exclusion criteria (1 listed)
- participation in an interventional clinical study
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 |
|---|---|---|
| rituximab [Mabthera/Rituxan]As prescribed by physician | Drug | Cohort |
Primary outcome
infusion-related adverse events
Time frame: data collection every 4-6 weeks for up to 6 months for each patient
1 secondary outcome
usage and applicability of 90-minute iv infusion in patients with CLL
Time frame: data collection every 4-6 weeks for up to 6 months for each patient
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 1 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
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphocytic Leukemia, Chronic, run by Hoffmann-La Roche at 18 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 4 inclusion and 1 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 1 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 18 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?
infusion-related adverse events (time frame: data collection every 4-6 weeks for up to 6 months for each patient). 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 1 Nov 2016.