Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the efficacy and safety of rituximab in combination with chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab + Fludarabine + Cyclophosphamide | Experimental | Participants will receive rituximab (375 milligrams per meter-squared [mg/m^2] intravenously [IV]) on Cycle 1 Day 1, followed by fludarabine (25 mg/m^2 once daily IV) and cyclophosphamide (250 mg/m^2 once daily IV) for Days 2 to 4 of Cycle 1. Then rituximab (500 mg/m^2 IV) will be administered on Day 1 of Cycles 2 to 6, followed by IV fludarabine (25 mg/m^2 once daily IV) and cyclophosphamide (250 mg/m^2 once daily IV) on Days 1 to 3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length, and the overall duration of treatment will be approximately 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide will be administered IV at 250 mg/m^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Death or Disease Progression | Treatment response was monitored throughout the study and assessed using standardized criteria. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (≥) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes. The percentage of participants with death or documented disease progression at any time during the study was calculated. | Up to 5 years (from Baseline until disease progression or death, whichever occurred first) |
| Progression-Free Survival (PFS) | Treatment response was monitored throughout the study and assessed using standardized criteria. Disease progression was defined as the occurrence of at least one of the following: ≥50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes. PFS was defined as the time from study inclusion until first event of disease progression or death and was estimated using Kaplan-Meier analysis. | Up to 5 years (from Baseline until disease progression or death, whichever occurred first) |
| Percentage of Participants Who Died | Participants were followed for survival throughout the study. The percentage of participants who died of any cause during the study was calculated. | Up to 5 years (from Baseline until death) |
| Overall Survival (OS) | Participants were followed for survival throughout the study. OS was defined as the time from study inclusion until death from any cause and was estimated using Kaplan-Meier analysis | Up to 5 years (from Baseline until death) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buenos Aires | 1406 | Argentina | ||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab + Fludarabine + Cyclophosphamide | Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via intravenous (IV) infusion as 375 milligrams per meter-squared (mg/m^2) on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All Participants Enrolled: All participants who complied with selection criteria at enrollment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab + Fludarabine + Cyclophosphamide | Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Death or Disease Progression | Treatment response was monitored throughout the study and assessed using standardized criteria. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (≥) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes. The percentage of participants with death or documented disease progression at any time during the study was calculated. | All Participants Enrolled. | Posted | Number | percentage of participants | Up to 5 years (from Baseline until disease progression or death, whichever occurred first) |
|
Up to 4 years (assessed every 4 weeks during 6-month treatment period, every 2 months during 6-month safety follow-up, then every 3 months during 3-year safety follow-up
Not provided
Not provided
| 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 with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | NCI-CTC (2.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | NCI-CTC (2.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
Not provided
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fludarabine | Drug | Fludarabine will be administered IV at 25 mg/m^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length. |
|
| Rituximab | Drug | Rituximab will be administered IV at 375 mg/m^2 on Day 1 of Cycle 1 and then at 500 mg/m^2 on Day 1 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length. |
|
|
| Percentage of Participants With Complete Response (CR), Nodular Partial Response (nPR), or Partial Response (PR) | Treatment response was monitored throughout the study and assessed using standardized criteria. CR was defined as hemoglobin ≥11 grams per deciliter (g/dL), lymphocytes less than (<) 4000 cells per cubic millimeter (cells/mm^3), neutrophils greater than (>) 1500 cells/mm^3, platelets >100,000 cells/mm^3, bone marrow (BM) biopsy with <30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, and performance status of 0. PR was defined as >50% decrease in size of enlarged lymph nodes, hepatomegaly, and splenomegaly, with peripheral counts meeting the same criteria as CR or ≥50% improvement from pre-treatment values. Participants with lymphoid nodules on BM biopsy who otherwise met CR criteria were considered nPR. The percentage of participants with each level of best overall response was calculated. | Up to 4 years (assessed every 3 months during 6-month treatment period, every 2 months during 6-month safety follow-up, then every 3 months during 3-year safety follow-up) |
| Buenos Aires |
| C1114AAN |
| Argentina |
| Buenos Aires | C1280AEB | Argentina |
| Buenos Aires | C1431FWO | Argentina |
| Córdoba | 5016 | Argentina |
| La Plata | B1897GOL | Argentina |
| Pilar | B1629ODT | Argentina |
| Rosario | S2000DSV | Argentina |
| Caracas | 2122 | Venezuela |
| Lost to Follow-up |
|
| Violation of Selection Criteria |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
|
|
| Primary | Progression-Free Survival (PFS) | Treatment response was monitored throughout the study and assessed using standardized criteria. Disease progression was defined as the occurrence of at least one of the following: ≥50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes. PFS was defined as the time from study inclusion until first event of disease progression or death and was estimated using Kaplan-Meier analysis. | All Participants Enrolled. | Posted | Mean | 95% Confidence Interval | months | Up to 5 years (from Baseline until disease progression or death, whichever occurred first) |
|
|
|
| Primary | Percentage of Participants Who Died | Participants were followed for survival throughout the study. The percentage of participants who died of any cause during the study was calculated. | All Participants Enrolled. | Posted | Number | percentage of participants | Up to 5 years (from Baseline until death) |
|
|
|
| Primary | Overall Survival (OS) | Participants were followed for survival throughout the study. OS was defined as the time from study inclusion until death from any cause and was estimated using Kaplan-Meier analysis | All Participants Enrolled. | Posted | Mean | 95% Confidence Interval | months | Up to 5 years (from Baseline until death) |
|
|
|
| Primary | Percentage of Participants With Complete Response (CR), Nodular Partial Response (nPR), or Partial Response (PR) | Treatment response was monitored throughout the study and assessed using standardized criteria. CR was defined as hemoglobin ≥11 grams per deciliter (g/dL), lymphocytes less than (<) 4000 cells per cubic millimeter (cells/mm^3), neutrophils greater than (>) 1500 cells/mm^3, platelets >100,000 cells/mm^3, bone marrow (BM) biopsy with <30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, and performance status of 0. PR was defined as >50% decrease in size of enlarged lymph nodes, hepatomegaly, and splenomegaly, with peripheral counts meeting the same criteria as CR or ≥50% improvement from pre-treatment values. Participants with lymphoid nodules on BM biopsy who otherwise met CR criteria were considered nPR. The percentage of participants with each level of best overall response was calculated. | All Participants Enrolled. | Posted | Number | percentage of participants | Up to 4 years (assessed every 3 months during 6-month treatment period, every 2 months during 6-month safety follow-up, then every 3 months during 3-year safety follow-up) |
|
|
|
| 15 |
| 34 |
| 18 |
| 34 |
| Neutropenia | Blood and lymphatic system disorders | NCI-CTC (2.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | NCI-CTC (2.0) | Non-systematic Assessment |
|
| Death | General disorders | NCI-CTC (2.0) | Non-systematic Assessment |
|
| Fever | General disorders | NCI-CTC (2.0) | Non-systematic Assessment |
|
| Infusion related reaction | General disorders | NCI-CTC (2.0) | Non-systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | NCI-CTC (2.0) | Non-systematic Assessment |
|
| Bronchial infection | Infections and infestations | NCI-CTC (2.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | NCI-CTC (2.0) | Non-systematic Assessment |
|
| Neoplasm (colon) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | NCI-CTC (2.0) | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | NCI-CTC (2.0) | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | NCI-CTC (2.0) | Non-systematic Assessment |
|
| Surgical and medical procedures (gallbladder) | Surgical and medical procedures | NCI-CTC (2.0) | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | NCI-CTC (2.0) | Non-systematic Assessment |
|
| Low platelets | Blood and lymphatic system disorders | NCI-CTC (2.0) | Non-systematic Assessment |
|
| Hypogammaglobulinemia | Blood and lymphatic system disorders | NCI-CTC (2.0) | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | NCI-CTC (2.0) | Non-systematic Assessment |
|
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.
| 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 |
| 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 |
| Title | Measurements |
|---|
|