Lymphocytic Leukemia, ChronicCaLLypsoNCT01609023
A Study of Rituximab (MabThera) in Combination With Chemotherapy in Participants With CD20-Positive B-Cell Chronic Lymphocytic Leukemia
An observational study of Lymphocytic Leukemia, Chronic, run by Hoffmann-La Roche at 9 sites in Greece.
Trial summary
This observational study will evaluate the safety and efficacy of rituximab in combination with chemotherapy in first- and second-line treatment of participants with cluster of differentiation 20 (CD20)-positive B-cell chronic lymphocytic leukemia. 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
- How many people
- 67 participants
- Where
- 9 sitesGreece
- Study dates
- Apr 2012to Nov 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy
Who may be able to join
- Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy according to the approved SPC
Who cannot join
- Contraindications to rituximab therapy according to the approved SPC
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Greece9 sites
University General Hospital of Alexandroupolis; Haemotology
Alexandroupoli, 68100
General Hospital of Athens Evangelismos; Hematology
Athens, 106 76
Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
Athens, 115 27
Metropolitan Hospital; Hematology Dept
Athens, 18547
Periph. University General Hospital of Heraklion; Hematology
Heraklion, 711 10
University Hospital of Larissa; Hematology Dept.
Larissa, 41110
General Hospital of Patras Agios Andreas; Hematology Department
Pátrai, 26335
University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division
Pátrai, 265 00
Georgios Papanikolaou Hospital; Hematology Department
Thessaloniki, 570 10
About this study
Official title: A Non-Interventional, Observational Phase IV Study to Evaluate Safety of Rituximab (Mabthera®) in Combination With Chemotherapy in Patients Treated With CD20+ Β Chronic Lymphocytic Leukemia
This observational study will evaluate the safety and efficacy of rituximab in combination with chemotherapy in first- and second-line treatment of participants with cluster of differentiation 20 (CD20)-positive B-cell chronic lymphocytic leukemia. Data will be collected from eligible participants receiving rituximab according to the Summary of Product Characteristics (SPC) during 6 months of treatment.
- Conditions
- Lymphocytic Leukemia, Chronic
- Being tested
- Rituximab
- 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.
RituximabDrug
Also called MabThera
Rituximab will be administered in combination with chemotherapy according to SPC and routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to SPC and routine clinical practice will be observed for 24 months. Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: Baseline up to 24 months
Secondary outcomes (6)
Progression-Free Survival (PFS) Assessed Using Local Standards
PFS was defined as the time from enrollment to the first documented progression of disease or death due to any cause. Progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. KaplanMeier estimate was used for analysis.
Measured: From enrollment until disease progression or death, assessed up to 24 months
Percentage of Participants With Disease Progression or Death Assessed Using Local Standards
PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Measured: Months 6, 12, 18, and 24
Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards
Percentage of participants with CR or PR as determined by the investigator was reported. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Months 6, 12, 18, and 24
Percentage of Participants With CR Assessed Using Local Standards
Percentage of participants with CR as determined by the investigator was reported. CR was defined as disappearance of all target lesions.
Measured: Months 6, 12, 18, and 24
Percentage of Participants With PR Assessed Using Local Standards
Percentage of participants with PR as determined by the investigator was reported. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Measured: Months 6, 12, 18, and 24
Time to Progression (TTP) Assessed Using Local Standards
TTP is defined as the time from enrollment to the PD. PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Kaplan-Meier estimate was used for analysis.
Measured: From enrollment until disease progression or death, assessed up to 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 67 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
- NCT01609023
- Sponsor's protocol ID
- ML22235
- Acronym
- CaLLypso
- Status last verified
- Apr 2018
- First submitted
- 29 May 2012
- Last updated
- 26 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional, Observational Phase IV Study to Evaluate Safety of Rituximab (Mabthera®) in Combination With Chemotherapy in Patients Treated With CD20+ Β Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT01609023
- Acronym / sponsor ID
- CaLLypso / ML22235
- Conditions
- Lymphocytic Leukemia, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 31 May 2012 (estimated)
- Results
- Posted 14 Jun 2017
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 evaluate the safety and efficacy of rituximab in combination with chemotherapy in first- and second-line treatment of participants with cluster of differentiation 20 (CD20)-positive B-cell chronic lymphocytic leukemia. Data will be collected from eligible participants receiving rituximab according to the Summary of Product Characteristics (SPC) during 6 months of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab | – | Drug: RituximabParticipants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to SPC and routine clinical practice will be observed for 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy
Key inclusion criteria (1 listed)
- Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy according to the approved SPC
Key exclusion criteria (1 listed)
- Contraindications to rituximab therapy according to the approved SPC
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 |
|---|---|---|
| RituximabAlso: MabTheraRituximab will be administered in combination with chemotherapy according to SPC and routine clinical practice. | Drug | Rituximab |
Primary outcome
Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline up to 24 months
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
6 secondary outcomes
Progression-Free Survival (PFS) Assessed Using Local Standards
Time frame: From enrollment until disease progression or death, assessed up to 24 months
Percentage of Participants With Disease Progression or Death Assessed Using Local Standards
Time frame: Months 6, 12, 18, and 24
Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards
Time frame: Months 6, 12, 18, and 24
Percentage of Participants With CR Assessed Using Local Standards
Time frame: Months 6, 12, 18, and 24
Percentage of Participants With PR Assessed Using Local Standards
Time frame: Months 6, 12, 18, and 24
Time to Progression (TTP) Assessed Using Local Standards
Time frame: From enrollment until disease progression or death, assessed up to 26 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
9 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 9 sites in Greece.
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 1 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 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Greece. 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?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (AEs) (time frame: Baseline up to 24 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 26 Jun 2018.