- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01609023
A Study of Rituximab (MabThera) in Combination With Chemotherapy in Participants With CD20-Positive B-Cell Chronic Lymphocytic Leukemia (CaLLypso)
April 5, 2018 updated by: Hoffmann-La Roche
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
67
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alexandroupolis, Greece, 68100
- University General Hospital of Alexandroupolis; Haemotology
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Athens, Greece, 106 76
- General Hospital of Athens Evangelismos; Hematology
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Athens, Greece, 18547
- Metropolitan Hospital; Hematology Dept
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Athens, Greece, 115 27
- Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
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Heraklion, Greece, 711 10
- Periph. University General Hospital of Heraklion; Hematology
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Larissa, Greece, 41110
- University Hospital of Larissa; Hematology Dept.
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Patra, Greece, 26335
- General Hospital of Patras Agios Andreas; Hematology Department
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Patras, Greece, 265 00
- University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division
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Thessaloniki, Greece, 570 10
- Georgios Papanikolaou Hospital; Hematology Department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy
Description
Inclusion Criteria:
- Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy according to the approved SPC
Exclusion Criteria:
- Contraindications to rituximab therapy according to the approved SPC
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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Rituximab will be administered in combination with chemotherapy according to SPC and routine clinical practice.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Adverse Events (AEs)
Time Frame: Baseline up to 24 months
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An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
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Baseline up to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival (PFS) Assessed Using Local Standards
Time Frame: From enrollment until disease progression or death, assessed up to 24 months
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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.
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From enrollment until disease progression or death, assessed up to 24 months
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Percentage of Participants With Disease Progression or Death Assessed Using Local Standards
Time Frame: Months 6, 12, 18, and 24
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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.
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Months 6, 12, 18, and 24
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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
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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.
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Months 6, 12, 18, and 24
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Percentage of Participants With CR Assessed Using Local Standards
Time Frame: Months 6, 12, 18, and 24
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Percentage of participants with CR as determined by the investigator was reported.
CR was defined as disappearance of all target lesions.
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Months 6, 12, 18, and 24
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Percentage of Participants With PR Assessed Using Local Standards
Time Frame: Months 6, 12, 18, and 24
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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.
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Months 6, 12, 18, and 24
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Time to Progression (TTP) Assessed Using Local Standards
Time Frame: From enrollment until disease progression or death, assessed up to 26 months
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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.
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From enrollment until disease progression or death, assessed up to 26 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
May 29, 2012
First Submitted That Met QC Criteria
May 29, 2012
First Posted (Estimate)
May 31, 2012
Study Record Updates
Last Update Posted (Actual)
June 26, 2018
Last Update Submitted That Met QC Criteria
April 5, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, B-Cell
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- ML22235
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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