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Completed

NCT Number: NCT01609023

A Study of Rituximab (MabThera) in Combination With Chemotherapy in Participants With CD20-Positive B-Cell 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.

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Key information

Conditions

Lymphocytic Leukemia, Chronic Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University General Hospital of Alexandroupolis; Haemotology, Alexandroupoli, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

Rituximab will be administered in combination with chemotherapy according to SPC and routine clinical practice.

Other names: MabThera

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: CaLLypso

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 31, 2012
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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