Lymphocytic Leukemia, Chronic, Chronic Lymphocytic Leukemia, CancerNCT02461316
Rituximab in Combination With Fludarabine and Cyclophosphamide in Patients With Chronic Lymphocytic Leukemia
An observational study of Lymphocytic Leukemia, Chronic, Chronic Lymphocytic Leukemia, Cancer, run by Hoffmann-La Roche at 3 sites in Serbia.
Trial summary
Evaluation of safety profile and tolerability of MabThera (rituximab) in combination with chemotherapy (fludarabine and cyclophosphamide) in the treatment of Chronic Lymphocytic Leukemia (CLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphocytic Leukemia, Chronic, Chronic Lymphocytic Leukemia, Cancer
- How many people
- 22 participants
- Where
- 3 sitesSerbia
- Study dates
- Jul 2009to Dec 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: Previously untreated patients with Chronic Lymphocytic Leukemia (CLL)
Who may be able to join
- Patients older than 18 years with diagnosed Chronic Lymphocytic Leukemia (CLL)
- CLL stages: Binet stage C (Rai III or IV), Binet stage B (Rai I and II) requiring treatment
Who cannot join
- Patients who are not eligible for rituximab treatment according to Summary of Product Characteristics (SmPC)
Trial locations and contacts
3 sites in 1 country.
Serbia3 sites
Study site
Belgrade, 11000
Study site
Kragujevac, 34000
Study site
Novi Sad, 21000
About this study
Official title: Open, Non-Interventional, Multicentre Trial of Rituximab in Combination With FC for the First-Line Therapy of Patients With Chronic Lymphocytic Leukaemia
Evaluation of safety profile and tolerability of MabThera (rituximab) in combination with chemotherapy (fludarabine and cyclophosphamide) in the treatment of Chronic Lymphocytic Leukemia (CLL).
- Being tested
- No intervention
- Medical subject headings
- Leukemia, Lymphoid, Bronchiolitis Obliterans Syndrome, Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention administered in this study: Rituximab in combination with fludarabine and cyclophosphamide for 6 months according to registered indication.
| Study group | Role | What they receive |
|---|---|---|
| Combination Treatment in Chronic Lymphocytic Leukemia (CLL) | All participants receiving combination treatment in Chronic Lymphocytic Leukemia (CLL) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Adverse Events (AEs)
Measured: From baseline to end of study up to 18 months
Percentage of Serious Adverse Events (SAEs)
Measured: From baseline to end of study up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startJul 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphocytic Leukemia, Chronic, Chronic Lymphocytic Leukemia, CancerStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 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
- NCT02461316
- Sponsor's protocol ID
- ML25066
- Status last verified
- Nov 2016
- First submitted
- 1 Jun 2015
- 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
- Open, Non-Interventional, Multicentre Trial of Rituximab in Combination With FC for the First-Line Therapy of Patients With Chronic Lymphocytic Leukaemia
- ClinicalTrials.gov ID
- NCT02461316
- Acronym / sponsor ID
- ML25066
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Jun 2015 (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.
Evaluation of safety profile and tolerability of MabThera (rituximab) in combination with chemotherapy (fludarabine and cyclophosphamide) in the treatment of Chronic Lymphocytic Leukemia (CLL).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Treatment in Chronic Lymphocytic Leukemia (CLL) | – | Other: No interventionAll participants receiving combination treatment in Chronic Lymphocytic Leukemia (CLL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Previously untreated patients with Chronic Lymphocytic Leukemia (CLL)
Key inclusion criteria (2 listed)
- Patients older than 18 years with diagnosed Chronic Lymphocytic Leukemia (CLL)
- CLL stages: Binet stage C (Rai III or IV), Binet stage B (Rai I and II) requiring treatment
Key exclusion criteria (1 listed)
- Patients who are not eligible for rituximab treatment according to Summary of Product Characteristics (SmPC)
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 |
|---|---|---|
| No interventionNo intervention administered in this study: Rituximab in combination with fludarabine and cyclophosphamide for 6 months according to registered indication. | Other | Combination Treatment in Chronic Lymphocytic Leukemia (CLL) |
Primary outcome
Percentage of Adverse Events (AEs)
Time frame: From baseline to end of study up to 18 months
Percentage of Serious Adverse Events (SAEs)
Time frame: From baseline to end of study up to 18 months
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
3 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, Chronic Lymphocytic Leukemia, Cancer, run by Hoffmann-La Roche at 3 sites in Serbia.
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 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 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 3 sites in Serbia. 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 Adverse Events (AEs) (time frame: From baseline to end of study up to 18 months). The study lists 2 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 2 Nov 2016.