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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012072-28 |
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This randomized, open-label, parallel group study will assess the effect on response rate and the safety of MabThera added to either bendamustine or chlorambucil in patients with chronic lymphocytic leukemia. Patients will be randomized to receive six 4-week cycles of either A) MabThera (375mg/m2 iv day 1 of cycle 1, 500mg/m2 iv cycles 2-6) plus bendamustine (90mg/m2 as first-line or 70mg/m2 as second-line therapy, iv on days 1 and 2, cycles 1-6), or B)MabThera plus chlorambucil (10mg/m2 po daily, days 1-7, cycles 1-6). Patients in group B can receive up to 6 further cycles of chlorambucil as monotherapy. Anticipated time on study treatment is 6-12 months, and target sample size is 600-700 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bendamustine | Drug | 90mg/m2 (first-line) or 70mg/m2 (second-line) iv, days 1 and 2 every 4 weeks, cycles 1-6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Confirmed Complete Response (CR) According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines in the First-Line Subpopulation After 6 Cycles of Therapy | The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes less than (<) 4 times 10^9 cells per liter (cells/L); absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to chronic lymphocytic leukemia (CLL) involvement; absence of constitutional symptoms; normal complete blood count (CBC) without need for transfusion or exogenous growth factors, as exhibited by neutrophils at least (>/=) 1.5 times 10^9 cells/L, platelets greater than (>) 100 times 10^9 cells/L, and hemoglobin > 11.0 grams per deciliter (g/dL); normocellular bone marrow (BM) aspirate with < 30 percent (%) lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100. | At least 2 months after completion of therapy (up to 32 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Pooled Population After 6 Cycles of Therapy | The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal CBC without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100. |
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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 |
|---|---|---|---|---|---|---|
| Pori | 28500 | Finland | ||||
Screening examination was performed within 28 days before randomization. Participants who fulfilled all the inclusion and none of the exclusion criteria were randomized to one of the two treatment groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab + Bendamustine | Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received intravenous (IV) rituximab 375 milligrams per square meter (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced progressive disease (PD). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| chlorambucil | Drug | 10mg/m2 po days 1-7 every 4 weeks, for up to 12 cycles |
|
| rituximab [MabThera/Rituxan] | Drug | 375mg/m2 iv day 1 of cycle 1, followed by 500mg/m2 iv every 4 weeks cycles 2-6 |
|
| At least 2 months after completion of therapy (up to 32 weeks) |
| Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Second-Line Subpopulation After 6 Cycles of Therapy | The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal CBC without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100. | At least 2 months after completion of therapy (up to 32 weeks) |
| Percentage of Participants Achieving a Best Overall Response of CR, CR With Incomplete Marrow Recovery (CRi), Partial Response (PR), or Nodular PR (nPR) in the First-Line Subpopulation | The criteria for CR are identified in previous outcome measure(s). Those fulfilling CR criteria but who have persistent anemia, thrombocytopenia, or neutropenia were considered CRi. The definition of PR required that the following be documented for minimum 2 months: >/= 50% decrease in peripheral blood lymphocytes from Baseline; reduction in lymphadenopathy; >/= 50% reduction in spleen or liver enlargement; and CBC with one of the following without need for transfusion or exogenous growth factors: polymorphonuclear leukocytes >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L or >/= 50% improvement from Baseline, or hemoglobin > 11.0 g/dL or >/= 50% improvement from Baseline. Participants with lymphoid nodules who otherwise met CR criteria were considered nPR. The percentage of participants achieving each level of response was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100. | After 3 and 6 treatment cycles and from Baseline to the end-of-treatment (EOT) visit, completed within 10 days before cutoff for data collection |
| Percentage of Participants by Disease Response Category in the First-Line Subpopulation | The criteria for CR, CRi, PR, and nPR are identified in previous outcome measure(s). PD was defined by at least one of the following: the presence of lymphadenopathy; an increase in the previously noted enlargement of the liver or spleen by >/= 50% or the de novo appearance of hepatomegaly or splenomegaly; an increase in the number of blood lymphocytes by >/= 50% with >/= 5000 B-cells per microliter (B-cells/mcL); transformation to a more aggressive histology; or occurrence of cytopenia attributable to CLL. Participants not achieving a CR or PR, and who did not exhibit PD, were considered to have stable disease (SD). The percentage of participants achieving each level of response was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed. The rows below are labeled first by the level of response at the end of 6 cycles (C6), then by level of response at the confirmation assessment. | After 6 treatment cycles and at the confirmation of response assessment at least 12 weeks later (up to 36 weeks) |
| Percentage of Participants Experiencing PD or Death in the First-Line Subpopulation | The criteria for PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100. | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| Progression-Free Survival (PFS) in the First-Line Subpopulation | The criteria for PD are identified in previous outcome measure(s). PFS was defined as the time from the first dose of trial treatment to the first documentation of PD or death, whichever occurred first. PFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44. | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| Percentage of Participants With Tumor Response of CR or CRi Experiencing PD or Death in the First-Line Subpopulation | The criteria for CR, CRi, and PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100. | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| Disease-Free Survival (DFS) in the First-Line Subpopulation | The criteria for CR, CRi, and PD are identified in previous outcome measure(s). DFS was defined as the time from the first assessment of CR or CRi to the first documentation of PD or death, whichever occurred first. DFS was calculated in months as [first event date minus first assessment date of CR/CRi plus 1] divided by 30.44. | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| Percentage of Participants Experiencing PD, Documented Intake of New Leukemia Therapy, or Death in the First-Line Subpopulation | The criteria for PD are identified in previous outcome measure(s). The percentage of participants experiencing PD, intake of new (post-trial) leukemia therapy, or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100. | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| Event-Free Survival (EFS) in the First-Line Subpopulation | The criteria for PD and SD are identified in previous outcome measure(s). EFS was defined as the time from the first dose of trial treatment to the first documentation of PD, the beginning of new treatment for any hematologic malignancy, or death from any cause. Those with SD were considered event-free. EFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44. | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| Percentage of Participants With Documented Intake of New Leukemia Therapy in the First-Line Subpopulation | The percentage of participants with documented intake of new (post-trial) leukemia therapy was calculated as the number of participants with new therapy divided by the number of participants analyzed, multiplied by 100. | During Cycles 1 to 6 (both treatment arms), Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| Time to Next Leukemia Treatment (TNLT) in the First-Line Subpopulation | TNLT was defined as the time from the first dose of trial treatment to the first documentation of any new leukemia treatment. TNLT was calculated in months as [first new treatment date minus first dose date plus 1] divided by 30.44. | During Cycles 1 to 6 (both treatment arms), Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| Percentage of Participants With Tumor Response of CR, CRi, PR, or nPR Experiencing PD or Death in the First-Line Subpopulation | The criteria for CR, CRi, PR, nPR, and PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100. | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| Duration of Response in the First-Line Subpopulation | The criteria for CR, CRi, PR, nPR, and PD are identified in previous outcome measure(s). Duration of response was defined as the time from the first assessment of CR, CRi, PR, or nPR to the first documentation of PD or death, whichever occurred first. Duration of response was calculated in months as [first event date minus first assessment date of CR/CRi/PR/nPR plus 1] divided by 30.44. | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| Percentage of Participants Experiencing Death in the First-Line Subpopulation | The percentage of participants experiencing death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100. | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| Overall Survival (OS) in the First-Line Subpopulation | OS was defined as the time from recorded diagnosis to death from any cause. OS was calculated in months as [death date or last-known alive date minus diagnosis date plus 1] divided by 30.44. | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| Percentage of Participants Achieving Molecular Response in the First-Line Subpopulation | Molecular response was defined as negative minimal residual disease (MRD) during study treatment or within 4 months after the end of treatment. Negative MRD was defined as a proportion of malignant B-cells in normal B-cells < 0.0001. The percentage of participants achieving molecular response was calculated as the number of participants with negative MRD divided by the number of participants analyzed. | Up to 4 months after the last treatment cycle (up to 40 weeks) |
| Number of Participants With Positive and Negative Outcome for MRD in the First-Line Subpopulation | Negative MRD was defined as a proportion of malignant B-cells in normal B-cells < 0.0001, and positive MRD was defined as a proportion of malignant B-cells in normal B-cells >/= 0.0001. | After 6 treatment cycles (up to 24 weeks) |
| Proportion of Malignant B-cells in Normal B-cells Among Participants With a Positive Outcome for MRD in the First-Line Subpopulation | The proportion of malignant B-cells in normal B-cells was quantitatively determined, and was calculated as the number of malignant B-cells divided by the number of normal B-cells observed. | After 6 treatment cycles (up to 24 weeks) |
| Vantaa |
| 01400 |
| Finland |
| Argenteuil | 95107 | France |
| Avignon | 84902 | France |
| Blois | 41016 | France |
| Bordeaux | 33076 | France |
| Brest | 29609 | France |
| La Roche-sur-Yon | 85925 | France |
| La Tronche | 38700 | France |
| Le Mans | 72037 | France |
| Lens | 62307 | France |
| Limoges | 87042 | France |
| Lyon | 69003 | France |
| Marseille | 13915 | France |
| Mulhouse | 68070 | France |
| Nice | 06202 | France |
| Nîmes | 30029 | France |
| Paris | 75571 | France |
| Paris | 75651 | France |
| Perpignan | 66046 | France |
| Pierre-Bénite | 69495 | France |
| Salouël | 80480 | France |
| Coimbra | 3000-075 | Portugal |
| Lisbon | 1099-166 | Portugal |
| Lisbon | 1600 | Portugal |
| Porto | 4200-072 | Portugal |
| Porto | 4200-319 | Portugal |
| Vitoria-Gasteiz | Alava | 01009 | Spain |
| Elche | Alicante | 03203 | Spain |
| Barcelona | Barcelona | 08025 | Spain |
| Barcelona | Barcelona | 08035 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Barcelona | Barcelona | 08907 | Spain |
| Barcelona | Barcelona | 08916 | Spain |
| Jerez de la Frontera | Cadiz | 11407 | Spain |
| Torrelavega | Cantabria | 39300 | Spain |
| Huelva | Huelva | 21005 | Spain |
| A Coruña | La Coruña | 15006 | Spain |
| León | Leon | 24071 | Spain |
| Alcorcón | Madrid | 28922 | Spain |
| Madrid | Madrid | 28006 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Madrid | Madrid | 28046 | Spain |
| Madrid | Madrid | 28222 | Spain |
| Madrid | Madrid | 28905 | Spain |
| Málaga | Malaga | 29010 | Spain |
| Cartagena | Murcia | 30203 | Spain |
| Murcia | Murcia | 30008 | Spain |
| Murcia | Murcia | 30120 | Spain |
| Salamanca | Salamanca | 37007 | Spain |
| Seville | Sevilla | 41009 | Spain |
| Tarragona | Tarragona | 43007 | Spain |
| Valencia | Valencia | 46014 | Spain |
| Zaragoza | Zaragoza | 50009 | Spain |
| Falun | 79182 | Sweden |
| Kristianstad | 29185 | Sweden |
| Luleå | S-971 80 | Sweden |
| Sundsvall | 85186 | Sweden |
| Uddevalla | 45180 | Sweden |
| Umeå | S-90185 | Sweden |
| Uppsala | 751 85 | Sweden |
| Tunis | 1008 | Tunisia |
| Ankara | 06100 | Turkey (Türkiye) |
| Ankara | 06500 | Turkey (Türkiye) |
| Ankara | 06620 | Turkey (Türkiye) |
| Bursa | 16059 | Turkey (Türkiye) |
| Edirne | 22050 | Turkey (Türkiye) |
| Istanbul | 34098 | Turkey (Türkiye) |
| Istanbul | 34390 | Turkey (Türkiye) |
| Izmir | 35100 | Turkey (Türkiye) |
| Kayseri | 38039 | Turkey (Türkiye) |
| Kocaeli | 41400 | Turkey (Türkiye) |
| Samsun | 55139 | Turkey (Türkiye) |
| Blackpool | FY3 8NR | United Kingdom |
| Bournemouth | BH7 7DW | United Kingdom |
| Edinburgh | EH4 2XU | United Kingdom |
| Leeds | LS9 7TF | United Kingdom |
| London | SE5 9RS | United Kingdom |
| Maidstone | ME16 9QQ | United Kingdom |
| Manchester | M20 4BX | United Kingdom |
| Manchester | OL1 2JH | United Kingdom |
| Oxford | OX3 7LJ | United Kingdom |
| Romford | RM7 0AG | United Kingdom |
| Somerset | TA1 5DA | United Kingdom |
| Truro | TR1 3LJ | United Kingdom |
| FG001 | Rituximab + Chlorambucil | Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally (PO) at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until complete response (CR) was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD. |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Treat (ITT) Population: all randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab + Bendamustine | Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD. |
| BG001 | Rituximab + Chlorambucil | Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD. |
| BG002 | Total | Total of all reporting groups |
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Achieving Confirmed Complete Response (CR) According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines in the First-Line Subpopulation After 6 Cycles of Therapy | The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes less than (<) 4 times 10^9 cells per liter (cells/L); absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to chronic lymphocytic leukemia (CLL) involvement; absence of constitutional symptoms; normal complete blood count (CBC) without need for transfusion or exogenous growth factors, as exhibited by neutrophils at least (>/=) 1.5 times 10^9 cells/L, platelets greater than (>) 100 times 10^9 cells/L, and hemoglobin > 11.0 grams per deciliter (g/dL); normocellular bone marrow (BM) aspirate with < 30 percent (%) lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100. | ITT Population (First-Line Subpopulation): A subset of participants requiring a first-line regimen for CLL. | Posted | Number | percentage of participants | At least 2 months after completion of therapy (up to 32 weeks) |
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| Secondary | Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Pooled Population After 6 Cycles of Therapy | The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal CBC without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100. | ITT Population | Posted | Number | percentage of participants | At least 2 months after completion of therapy (up to 32 weeks) |
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| Secondary | Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Second-Line Subpopulation After 6 Cycles of Therapy | The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal CBC without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100. | ITT Population (Second-Line Subpopulation): A subset of participants requiring a second-line regimen for CLL. | Posted | Number | percentage of participants | At least 2 months after completion of therapy (up to 32 weeks) |
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| Secondary | Percentage of Participants Achieving a Best Overall Response of CR, CR With Incomplete Marrow Recovery (CRi), Partial Response (PR), or Nodular PR (nPR) in the First-Line Subpopulation | The criteria for CR are identified in previous outcome measure(s). Those fulfilling CR criteria but who have persistent anemia, thrombocytopenia, or neutropenia were considered CRi. The definition of PR required that the following be documented for minimum 2 months: >/= 50% decrease in peripheral blood lymphocytes from Baseline; reduction in lymphadenopathy; >/= 50% reduction in spleen or liver enlargement; and CBC with one of the following without need for transfusion or exogenous growth factors: polymorphonuclear leukocytes >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L or >/= 50% improvement from Baseline, or hemoglobin > 11.0 g/dL or >/= 50% improvement from Baseline. Participants with lymphoid nodules who otherwise met CR criteria were considered nPR. The percentage of participants achieving each level of response was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100. | ITT Population (First-Line Subpopulation) | Posted | Number | 95% Confidence Interval | percentage of participants | After 3 and 6 treatment cycles and from Baseline to the end-of-treatment (EOT) visit, completed within 10 days before cutoff for data collection |
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| Secondary | Percentage of Participants by Disease Response Category in the First-Line Subpopulation | The criteria for CR, CRi, PR, and nPR are identified in previous outcome measure(s). PD was defined by at least one of the following: the presence of lymphadenopathy; an increase in the previously noted enlargement of the liver or spleen by >/= 50% or the de novo appearance of hepatomegaly or splenomegaly; an increase in the number of blood lymphocytes by >/= 50% with >/= 5000 B-cells per microliter (B-cells/mcL); transformation to a more aggressive histology; or occurrence of cytopenia attributable to CLL. Participants not achieving a CR or PR, and who did not exhibit PD, were considered to have stable disease (SD). The percentage of participants achieving each level of response was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed. The rows below are labeled first by the level of response at the end of 6 cycles (C6), then by level of response at the confirmation assessment. | ITT Population (First-Line Subpopulation) | Posted | Number | percentage of participants | After 6 treatment cycles and at the confirmation of response assessment at least 12 weeks later (up to 36 weeks) |
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| Secondary | Percentage of Participants Experiencing PD or Death in the First-Line Subpopulation | The criteria for PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100. | ITT Population (First-Line Subpopulation) | Posted | Number | percentage of participants | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
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| Secondary | Progression-Free Survival (PFS) in the First-Line Subpopulation | The criteria for PD are identified in previous outcome measure(s). PFS was defined as the time from the first dose of trial treatment to the first documentation of PD or death, whichever occurred first. PFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44. | ITT Population (First-Line Subpopulation) | Posted | Median | 95% Confidence Interval | months | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
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| Secondary | Percentage of Participants With Tumor Response of CR or CRi Experiencing PD or Death in the First-Line Subpopulation | The criteria for CR, CRi, and PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100. | ITT Population (First-Line Subpopulation); only participants with a tumor response of CR or CRi during study treatment or within 4 months after the end of treatment were considered in the analysis. | Posted | Number | percentage of participants | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease-Free Survival (DFS) in the First-Line Subpopulation | The criteria for CR, CRi, and PD are identified in previous outcome measure(s). DFS was defined as the time from the first assessment of CR or CRi to the first documentation of PD or death, whichever occurred first. DFS was calculated in months as [first event date minus first assessment date of CR/CRi plus 1] divided by 30.44. | ITT Population (First-Line Subpopulation); only participants with a tumor response of CR or CRi during study treatment or within 4 months after the end of treatment were considered in the analysis. | Posted | Median | 95% Confidence Interval | months | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing PD, Documented Intake of New Leukemia Therapy, or Death in the First-Line Subpopulation | The criteria for PD are identified in previous outcome measure(s). The percentage of participants experiencing PD, intake of new (post-trial) leukemia therapy, or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100. | ITT Population (First-Line Subpopulation) | Posted | Number | percentage of participants | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Event-Free Survival (EFS) in the First-Line Subpopulation | The criteria for PD and SD are identified in previous outcome measure(s). EFS was defined as the time from the first dose of trial treatment to the first documentation of PD, the beginning of new treatment for any hematologic malignancy, or death from any cause. Those with SD were considered event-free. EFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44. | ITT Population (First-Line Subpopulation) | Posted | Median | 95% Confidence Interval | months | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Documented Intake of New Leukemia Therapy in the First-Line Subpopulation | The percentage of participants with documented intake of new (post-trial) leukemia therapy was calculated as the number of participants with new therapy divided by the number of participants analyzed, multiplied by 100. | ITT Population (First-Line Subpopulation) | Posted | Number | percentage of participants | During Cycles 1 to 6 (both treatment arms), Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Next Leukemia Treatment (TNLT) in the First-Line Subpopulation | TNLT was defined as the time from the first dose of trial treatment to the first documentation of any new leukemia treatment. TNLT was calculated in months as [first new treatment date minus first dose date plus 1] divided by 30.44. | ITT Population (First-Line Subpopulation) | Posted | Median | 95% Confidence Interval | months | During Cycles 1 to 6 (both treatment arms), Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Tumor Response of CR, CRi, PR, or nPR Experiencing PD or Death in the First-Line Subpopulation | The criteria for CR, CRi, PR, nPR, and PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100. | ITT Population (First-Line Subpopulation); only participants with a tumor response of CR, CRi, PR, or nPR were considered in the analysis. | Posted | Number | percentage of participants | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response in the First-Line Subpopulation | The criteria for CR, CRi, PR, nPR, and PD are identified in previous outcome measure(s). Duration of response was defined as the time from the first assessment of CR, CRi, PR, or nPR to the first documentation of PD or death, whichever occurred first. Duration of response was calculated in months as [first event date minus first assessment date of CR/CRi/PR/nPR plus 1] divided by 30.44. | ITT Population (First-Line Subpopulation); only participants with a tumor response of CR, CRi, PR, or nPR were considered in the analysis. | Posted | Median | 95% Confidence Interval | months | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Death in the First-Line Subpopulation | The percentage of participants experiencing death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100. | ITT Population (First-Line Subpopulation) | Posted | Number | percentage of participants | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in the First-Line Subpopulation | OS was defined as the time from recorded diagnosis to death from any cause. OS was calculated in months as [death date or last-known alive date minus diagnosis date plus 1] divided by 30.44. | ITT Population (First-Line Subpopulation) | Posted | Median | 95% Confidence Interval | months | End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Molecular Response in the First-Line Subpopulation | Molecular response was defined as negative minimal residual disease (MRD) during study treatment or within 4 months after the end of treatment. Negative MRD was defined as a proportion of malignant B-cells in normal B-cells < 0.0001. The percentage of participants achieving molecular response was calculated as the number of participants with negative MRD divided by the number of participants analyzed. | ITT Population (First-Line Subpopulation); only participants with a tumor response of CR, CRi, PR, or nPR during study treatment or within 4 months after the end of treatment were considered in the analysis. | Posted | Number | percentage of participants | Up to 4 months after the last treatment cycle (up to 40 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive and Negative Outcome for MRD in the First-Line Subpopulation | Negative MRD was defined as a proportion of malignant B-cells in normal B-cells < 0.0001, and positive MRD was defined as a proportion of malignant B-cells in normal B-cells >/= 0.0001. | ITT Population (First-Line Subpopulation); only participants with available MRD data (MRD-evaluable participants) were included in the analysis. | Posted | Number | participants | After 6 treatment cycles (up to 24 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Malignant B-cells in Normal B-cells Among Participants With a Positive Outcome for MRD in the First-Line Subpopulation | The proportion of malignant B-cells in normal B-cells was quantitatively determined, and was calculated as the number of malignant B-cells divided by the number of normal B-cells observed. | ITT Population (First-Line Subpopulation); only participants with a positive outcome for MRD were included in the analysis. | Posted | Mean | Standard Deviation | proportion | After 6 treatment cycles (up to 24 weeks) |
|
From Baseline up to 8 weeks after the start of the last treatment cycle (nonserious adverse events [AEs]; up to 56 weeks) or until the EOT visit (serious AEs; up to 4.5 years)
Based upon the pooled population including both first-line and second line participants
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 + Bendamustine | Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD. | 73 | 177 | 165 | 177 | ||
| EG001 | Rituximab + Chlorambucil | Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD. | 56 | 178 | 159 | 178 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Listeria sepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cardiac fibrillation | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Ill-defined disorder | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| International normalized ratio increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Adjustment disorder | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vascular occlusion | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.0) | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| D002699 | Chlorambucil |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic 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 |
Not provided
Not provided
| Male |
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| No confirmed CR |
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| OG001 | Rituximab + Chlorambucil | Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD. |
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| OG001 | Rituximab + Chlorambucil | Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD. |
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| OG001 | Rituximab + Chlorambucil | Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD. |
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| OG001 | Rituximab + Chlorambucil | Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD. |
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Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
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Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD. |
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Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
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Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD. |
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