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This multi-center, single-arm study evaluated the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide in participants with B-cell chronic lymphocytic leukemia (CLL) and favorable somatic status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab + Fludarabine + Cyclophosphamide | Experimental | Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Participants received cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Remission | Complete remission was defined as the disappearance of all signs of disease. | Up to approximately 5 years |
| Percentage of Participants With Disease Progression | Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. | Up to approximately 5 years |
| Percentage of Participants With Stable Disease | Stable disease was defined as not meeting the criteria for partial remission or disease progression | Up to approximately 5 years |
| Percentage of Participants With Partial Remission | Partial remission was defined as a reduction in tumor size by >50%. | Up to approximately 5 years |
| Duration of Response | Duration of Response was defined as the time period from the last day of study treatment to the day when disease progression occurred in participants who previously had complete or partial remission. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%. | Up to approximately 5 years |
| Progression-free Survival | Progression-free survival was defined as the time period from the first day of study treatment to the day when disease progression occurred. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The order of Honour pin Irkutsk regional clinical hospital; Hematology Department | Irkutsk | 664079 | Russia | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab + Fludarabine + Cyclophosphamide | Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Fludarabine | Drug | Participants received fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle. |
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| Rituximab | Drug | Participants received 375 mg/m^2 IV on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle. |
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| Up to approximately 5 years |
| Event-free Survival | Event-free survival was defined as the time period from the first day of study treatment to occurrence of any of the following events: appearance of disease progression or relapse; prescription of a new treatment for disease relapse; death caused by B-cell chronic lymphocytic leukemia (B-CLL); or complications from B-CLL or therapy. Relapse was defined as disease progression in participants with complete or partial remission lasting at least 6 months after treatment completion. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%. | Up to approximately 5 years |
| Overall Survival | Overall survival was defined as the time period from the first day of study treatment to participant death. | Up to approximately 5 years |
| Percentage of Participants With Phenotypic Remission | Phenotypic remission was considered achieved if a participant had a negative test for minimal residual disease. A negative test for minimal residual disease was defined as tumor cells ≤0.01% of the total number of peripheral leukocytes. | Up to approximately 5 years |
| Percentage of Participants With Adverse Events (AEs) and Serious AEs | An AE was defined as any unfavorable medical occurrence in a participant receiving a study drug, regardless of relationship the study drug. An AE was considered serious if it met any of the following criteria: was fatal or life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was clinically significant and/or required an intervention to prevent any of the listed criteria. | Up to approximately 5 years |
| Kemerovo Regional Clinical Hospital |
| Kemerovo |
| 650066 |
| Russia |
| Regional Clinical Oncology Despensary #1; Hematology Department | Krasnodar | 350040 | Russia |
| N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis | Moscow | 115478 | Russia |
| City Clinical Hospital After Botkin; Hematology | Moscow | 125101 | Russia |
| Saint-Petersburg SHI City Clinical Hospital #31 | Saint Petersburg | 197110 | Russia |
| City Clinical Hospital #15; Hematology department | Saint Petersburg | 198205 | Russia |
| Leningrad Regional Clinical Hospital; Hematology #1 | Saint Petersburg | Russia |
| GUZ Tula Regioanal Clinical Hospital; Hematology | Tula | 300053 | Russia |
| Republican clinical hospital named after G.G. Kuvatov | Ufa | 450005 | Russia |
| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab + Fludarabine + Cyclophosphamide | Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each. |
| 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 |
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| 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 Complete Remission | Complete remission was defined as the disappearance of all signs of disease. | All enrolled participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Up to approximately 5 years |
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| Primary | Percentage of Participants With Disease Progression | Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. | All enrolled participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Up to approximately 5 years |
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| |||||||||||||||||||||||||||
| Primary | Percentage of Participants With Stable Disease | Stable disease was defined as not meeting the criteria for partial remission or disease progression | All enrolled participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Up to approximately 5 years |
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| |||||||||||||||||||||||||||
| Primary | Percentage of Participants With Partial Remission | Partial remission was defined as a reduction in tumor size by >50%. | All enrolled participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Up to approximately 5 years |
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| Primary | Duration of Response | Duration of Response was defined as the time period from the last day of study treatment to the day when disease progression occurred in participants who previously had complete or partial remission. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%. | Enrolled participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | days | Up to approximately 5 years |
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| Primary | Progression-free Survival | Progression-free survival was defined as the time period from the first day of study treatment to the day when disease progression occurred. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. | Enrolled participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | days | Up to approximately 5 years |
|
| ||||||||||||||||||||||||||
| Primary | Event-free Survival | Event-free survival was defined as the time period from the first day of study treatment to occurrence of any of the following events: appearance of disease progression or relapse; prescription of a new treatment for disease relapse; death caused by B-cell chronic lymphocytic leukemia (B-CLL); or complications from B-CLL or therapy. Relapse was defined as disease progression in participants with complete or partial remission lasting at least 6 months after treatment completion. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%. | Enrolled participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | days | Up to approximately 5 years |
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| Primary | Overall Survival | Overall survival was defined as the time period from the first day of study treatment to participant death. | Enrolled participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | days | Up to approximately 5 years |
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| Primary | Percentage of Participants With Phenotypic Remission | Phenotypic remission was considered achieved if a participant had a negative test for minimal residual disease. A negative test for minimal residual disease was defined as tumor cells ≤0.01% of the total number of peripheral leukocytes. | Enrolled participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Up to approximately 5 years |
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| Primary | Percentage of Participants With Adverse Events (AEs) and Serious AEs | An AE was defined as any unfavorable medical occurrence in a participant receiving a study drug, regardless of relationship the study drug. An AE was considered serious if it met any of the following criteria: was fatal or life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was clinically significant and/or required an intervention to prevent any of the listed criteria. | All enrolled participants. | Posted | Number | percentage of participants | Up to approximately 5 years |
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Up to approximately 5 years
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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 + Fludarabine + Cyclophosphamide | Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each. | 12 | 89 | 70 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes zoster | Infections and infestations | MedDRA, version 18.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA, version 18.1 | Systematic Assessment |
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| Peritonitis | Infections and infestations | MedDRA, version 18.1 | Systematic Assessment |
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| Proctitis infectious | Infections and infestations | MedDRA, version 18.1 | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA, version 18.1 | Systematic Assessment |
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| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA, version 18.1 | Systematic Assessment |
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| Squamous cell carcinoma of lung | Respiratory, thoracic and mediastinal disorders | MedDRA, version 18.1 | Systematic Assessment |
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| Agranulocytosis | Blood and lymphatic system disorders | MedDRA, version 18.1 | Systematic Assessment |
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| Neuroendocrine tumour | Endocrine disorders | MedDRA, version 18.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA, version 18.1 | Systematic Assessment |
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| Duodenal ulcer | Gastrointestinal disorders | MedDRA, version 18.1 | Systematic Assessment |
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| Brain contusion | Injury, poisoning and procedural complications | MedDRA, version 18.1 | Systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | MedDRA, version 18.1 | Systematic Assessment |
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| Contusion | Musculoskeletal and connective tissue disorders | MedDRA, version 18.1 | Systematic Assessment |
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| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 18.1 | Systematic Assessment |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA, version 18.1 | Systematic Assessment |
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| Duodenal ulcer haemorrhage | Vascular disorders | MedDRA, version 18.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophil count decreased | Investigations | MedDRA, version 18.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA, version 18.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA, version 18.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA, version 18.1 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA, version 18.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA, version 18.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA, version 18.1 | 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-LaRoche | 1-800-821-8590 | 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 |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| 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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