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

Status

Completed

Conditions

Intervention / Treatment

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

  • Greece
      • Alexandroupolis, Greece, 68100
        • University General Hospital of Alexandroupolis; Haemotology
      • Athens, Greece, 106 76
        • General Hospital of Athens Evangelismos; Hematology
      • Athens, Greece, 18547
        • Metropolitan Hospital; Hematology Dept
      • Athens, Greece, 115 27
        • Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
      • Heraklion, Greece, 711 10
        • Periph. University General Hospital of Heraklion; Hematology
      • Larissa, Greece, 41110
        • University Hospital of Larissa; Hematology Dept.
      • Patra, Greece, 26335
        • General Hospital of Patras Agios Andreas; Hematology Department
      • Patras, Greece, 265 00
        • University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division
      • Thessaloniki, Greece, 570 10
        • Georgios Papanikolaou Hospital; Hematology Department

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.
Drug: Rituximab
Rituximab will be administered in combination with chemotherapy according to SPC and routine clinical practice.
Other Names:
  • MabThera

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
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Baseline up to 24 months

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
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.
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
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.
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 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.
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 CR as determined by the investigator was reported. CR was defined as disappearance of all target lesions.
Months 6, 12, 18, and 24
Percentage of Participants With PR Assessed Using Local Standards
Time Frame: Months 6, 12, 18, and 24
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.
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
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.
From enrollment until disease progression or death, assessed up to 26 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

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

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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