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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab will be administered in combination with chemotherapy according to SPC and routine clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
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Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University General Hospital of Alexandroupolis; Haemotology | Alexandroupoli | 68100 | Greece | |||
| General Hospital of Athens Evangelismos; Hematology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab | Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. | 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. | 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. | 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. | 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. | From enrollment until disease progression or death, assessed up to 26 months |
| Athens |
| 106 76 |
| Greece |
| Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine | Athens | 115 27 | Greece |
| Metropolitan Hospital; Hematology Dept | Athens | 18547 | Greece |
| Periph. University General Hospital of Heraklion; Hematology | Heraklion | 711 10 | Greece |
| University Hospital of Larissa; Hematology Dept. | Larissa | 41110 | Greece |
| General Hospital of Patras Agios Andreas; Hematology Department | Pátrai | 26335 | Greece |
| University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division | Pátrai | 265 00 | Greece |
| Georgios Papanikolaou Hospital; Hematology Department | Thessaloniki | 570 10 | Greece |
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| NOT COMPLETED |
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Intent-to-treat (ITT) population included all eligible participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab | Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety population included all eligible participants. | Posted | Number | percentage of participants | Baseline up to 24 months |
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| Secondary | 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. | ITT population | Posted | Median | 95% Confidence Interval | months | From enrollment until disease progression or death, assessed up to 24 months |
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| Secondary | 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. | ITT population. Here, 'Overall Number of Participants Analyzed' = number of participants who were evaluable for this outcome. 'Number Analyzed' = participants who were evaluable for specified timepoints. | Posted | Number | percentage of participants | Months 6, 12, 18, and 24 |
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| Secondary | 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. | ITT population. Here, 'Overall Number of Participants Analyzed' = number of participants who were evaluable for this outcome. 'Number Analyzed' = participants who were evaluable for specified timepoints. | Posted | Number | percentage of participants | Months 6, 12, 18, and 24 |
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| Secondary | 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. | ITT population. Here, 'Overall Number of Participants Analyzed' = number of participants who were evaluable for this outcome. 'Number Analyzed' = participants who were evaluable for specified timepoints. | Posted | Number | percentage of participants | Months 6, 12, 18, and 24 |
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| Secondary | 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. | ITT population. Here, 'Overall Number of Participants Analyzed' = number of participants who were evaluable for this outcome. 'Number Analyzed' = participants who were evaluable for specified timepoints. | Posted | Number | percentage of participants | Months 6, 12, 18, and 24 |
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| Secondary | 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. | ITT population | Posted | Mean | 95% Confidence Interval | months | From enrollment until disease progression or death, assessed up to 26 months |
|
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Baseline up to 24 months
Safety population
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rituximab | Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months. | 33 | 67 | 47 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Eosinophilia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Death | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Disease progression | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Drug-induced liver injury | Hepatobiliary disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Non-systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Non-systematic Assessment |
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| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 19.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Spinal operation | Surgical and medical procedures | MedDRA Version 19.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA Version 19.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 19.1 | Non-systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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