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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003388-79 | EudraCT Number |
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This phase II trial was designed to evaluate the efficacy of obinutuzumab and bendamustine treatment in participants with refractory or relapsed chronic lymphocytic leukemia (CLL). Participants receive up to six 28-day cycles of treatment. Treatment consists of intravenous (IV) administration of obinutuzumab and bendamustine. Treatment time is expected to last 6 months, and participant follow-up will last 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obinutuzmab + Bendamustine | Experimental | Participants will receive obinutuzumab and bendamustine in 28-days cycles for a maximum of 6 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bendamustine | Drug | 70 milligrams per square meter (mg/m^2) given by intravenous (IV) infusion on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of subsequent cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria | ORR was defined as percentage of participants achieving Complete Response (CR), incomplete CR (CRi) or Partial Response (PR). CR: lymphocytes below 4 x 10^9/L, absence of lymphadenopathy, hepatomegaly and splenomegaly, absence of disease or constitutional symptoms, neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 110 g/L, bone marrow at least normocellular for age. CRi: CR with persistent cytopenia, i.e. anemia, thrombocytopenia and/or neutropenia. PR: reduction ≥ 50% of the lymphocyte count AND reduction ≥ 50% of the lymphadenopathy OR reduction ≥ 50% of the size of the liver if enlarged at baseline OR reduction ≥ 50% of the size of the spleen if enlarged at baseline PLUS one of the following: neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 110 g/L or increase ≥ 50% compared to pre-treatment. | 2-3 months after last dose of the study treatment (up to approximately 9 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Best Response Rate as Assessed by the Investigator Using the IWCLL 2008 Criteria | Best overall response was defined as percentage of participants achieving a best response of CR, CRi and PR. CR: lymphocytes below 4 x 10^9/L, absence of lymphadenopathy, hepatomegaly and splenomegaly, absence of disease or constitutional symptoms, neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 110 g/L, bone marrow at least normocellular for age. CRi: CR with persistent cytopenia, i.e. anemia, thrombocytopenia and/or neutropenia. PR: reduction ≥ 50% of the lymphocyte count AND reduction ≥ 50% of the lymphadenopathy OR reduction ≥ 50% of the size of the liver if enlarged at baseline OR reduction ≥ 50% of the size of the spleen if enlarged at baseline PLUS one of the following: neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 110 g/L or increase ≥ 50% compared to pre-treatment. |
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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 |
|---|---|---|---|---|---|---|
| Hospital De Txagorritxu; Servicio de Hematologia | Vitoria-Gasteiz | Alava | 01009 | Spain | ||
| Hospital General Universitario de Elche; Servicio de Hematologia |
Participants enrolled in the study had documented CD20-positive B-cell type relapsed or refractory chronic lymphocytic leukemia (CLL).
A total of 72 participants were recruited at 20 sites in Spain.
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| ID | Title | Description |
|---|---|---|
| FG000 | Obinutuzumab + Bendamustine | Participants received obinutuzumab and bendamustine in 28-days cycles for a maximum of 6 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2017 |
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| obinutuzumab | Drug | 1000 mg given by IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of subsequent cycles. |
|
|
| During study treatment and until 6 months after end of study treatment at approximately 12 months |
| Progression Free Survival (PFS) | PFS is defined as the time from the start of treatment to disease progression (DP), relapse or death from any cause, whichever occurs first, as assessed by the investigator. DP: at least one of the following characteristics: increase ≥ 50% in lymphocytes up to at least 5 x 10^9/L, appearance of new palpable lymph nodes, increase ≥ 50% of the longest diameter of any previous area of clinically significant lymphadenopathy, increase ≥ 50% of the size of the liver and/or spleen, transformation to a more aggressive histology, after treatment progression of any cytopenia: decrease of hemoglobin levels of more than 20 g/L or to below 100 g/L and/or decrease of platelet counts by more than 50% or to below 100 x 10^9/L and/or decrease in the neutrophil counts by more than 50% or to below 1.0 x 10^9/L if the marrow biopsy also shows infiltration of clonal chronic lymphocytic leukemia (CLL) cells. | From start of treatment up to disease progression or relapse or death, whichever occurred first (up to approximately 4.5 years) |
| Overall Survival (OS) | OS was defined as the time from the start of study treatment to death from any cause. | From start of treatment up to death of any cause (up to approximately 4.5 years) |
| Event Free Survival (EFS) | EFS was defined as the time from the start of treatment to DP/relapse, death from any cause or start of a new anti-leukemia therapy. DP: at least one of the following characteristics: increase ≥ 50% in lymphocytes up to at least 5 x 10^9/L, appearance of new palpable lymph nodes, increase ≥ 50% of the longest diameter of any previous area of clinically significant lymphadenopathy, increase ≥ 50% of the size of the liver and/or spleen, transformation to a more aggressive histology, after treatment, progression of any cytopenia: decrease of hemoglobin levels of more than 20 g/L or to below 100 g/L and/or decrease of platelet counts by more than 50% or to below 100 x 10^9/L and/or decrease in the neutrophil counts by more than 50% or to below 1.0 x 10^9/L if the marrow biopsy also shows infiltration of clonal CLL cells. | From start of treatment up to disease progression or relapse or death or start of a new anti-leukemic therapy, whichever occurred first (up to approximately 4.5 years) |
| Disease Free Survival (DFS) | DFS was defined for all participants who achieved complete response (CRi or CR). DFS lasted from the date on which CRi or CR was recorded until the date on which the first DP or death from any cause occurred. DP: at least one of the following characteristics: increase ≥ 50% in lymphocytes up to at least 5 x 10^9/L, appearance of new palpable lymph nodes, increase ≥ 50% of the longest diameter of any previous area of clinically significant lymphadenopathy, increase ≥ 50% of the size of the liver and/or spleen, transformation to a more aggressive histology, after treatment, progression of any cytopenia: decrease of hemoglobin levels of more than 20 g/L or to below 100 g/L and/or decrease of platelet counts by more than 50% or to below 100 x 10^9/L and/or decrease in the neutrophil counts by more than 50% or to below 1.0 x 10^9/L if the marrow biopsy also shows infiltration of clonal CLL cells. | From occurrence of complete response up to disease progression or death, whichever occurred first (up to approximately 4.5 years) |
| Duration of Response (DR) | DR was defined for participants with CRi, CR or PR. DR spanned from the date on which response was recorded until the date on which DP or death from any cause occurred. DP: at least one of the following characteristics: increase ≥ 50% in lymphocytes up to at least 5 x 10^9/L, appearance of new palpable lymph nodes, increase ≥ 50% of the longest diameter of any previous area of clinically significant lymphadenopathy, increase ≥ 50% of the size of the liver and/or spleen, transformation to a more aggressive histology, after treatment, progression of any cytopenia: decrease of hemoglobin levels of more than 20 g/L or to below 100 g/L and/or decrease of platelet counts by more than 50% or to below 100 x 10^9/L and/or decrease in the neutrophil counts by more than 50% or to below 1.0 x 10^9/L if the marrow biopsy also shows infiltration of clonal CLL cells. | From occurrence of CR or PR up to disease progression or death, whichever occurred first (up to approximately 4.5 years) |
| Time to Re-treatment/New Anti-leukemia Therapy | Time to re-treatment/new leukemia therapy was defined as the time between the start of treatment and the date of the first administration of re-treatment or new leukemia therapy. | Up to 4.5 years |
| Percentage of Participants With Minimal Residual Disease (MRD) Negativity | MRD negativity was defined as the presence of less than 1 cell of CLL per 10,000 leukocytes (= category 0, <0.01%) assessed in bone marrow (BM) and peripheral blood (PB) by flow cytometry after the end of the treatment at the final response assessment. | At approximately 9 months |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. An SAE was any AE that was any of the following: fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, and was considered a significant medical event by the investigator. | Up to approximately 4.5 years |
| Percentage of Participants With AEs of Special Interest (AESIs) | AESIs included any of the following: SAEs associated with the infusion of obinutuzumab: obinutuzumab serious infusion-related reactions, which were defined as AEs occurring during or within 24 hours following the administration of an infusion of obinutuzumab and considered related to obinutuzumab; serious infection; serious neutropenia; any tumor lysis syndrome (TLS); second malignancies. | Up to approximately 4.5 years |
| Percentage of Participants With Infusion-related Reactions (IRRs) | IRRs were defined as AEs occurring during or within 24 hours following the administration of an infusion and considered related to drug treatment. | Up to end of treatment at 6 months |
| Percentage of Participants Who Discontinued Treatment Prematurely | Up to end of treatment at 6 months |
| Percentage of Participants With Previous/Concomitant Diseases | Up to approximately 4.5 years |
| Percentage of Participants With Concomitant Medication | Concomitant therapies included any medication (prescription medication, over-the-counter medications, herbal/homeopathic remedies, nutritional supplements) used by subjects in the 7 days prior to screening until the end of treatment. The following treatments were not permitted during the study treatment period: investigational or unauthorized or unapproved medicinal products, immunotherapy or radioimmunotherapy (other than the trial immunotherapy, obinutuzumab), chemotherapy (other than the trial chemotherapy, bendamustine) and radiotherapy. | From 7 days prior to screening to the end of treatment at 6 months |
| Elche |
| Alicante |
| 03203 |
| Spain |
| Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia | Badalona | Barcelona | 08915 | Spain |
| Hospital Mutua de Terrassa; Servicio de Hematologia | Terrassa | Barcelona | 08221 | Spain |
| Hospital General de Castellon; Servicio de Hematologia | Castellon | Castellon | 12004 | Spain |
| Hospital de Navarra, Servicio de HematologÃa | Pamplona | Navarre | 31008 | Spain |
| Hospital de Cabueñes; Servicio de HematologÃa y Hemoterapia | Gijón | Principality of Asturias | 33203 | Spain |
| Hospital Univ. Central de Asturias; servicio de Hematologia | Oviedo | Principality of Asturias | 33011 | Spain |
| Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Hematologia | Santa Cruz de Tenerife | Tenerife | 38010 | Spain |
| Hospital Universitari Vall d'Hebron; Servicio de Hematologia | Barcelona | 08035 | Spain |
| Hospital ClÃnic i Provincial; Servicio de HematologÃa y OncologÃa | Barcelona | 08036 | Spain |
| Hospital Universitario Virgen de las Nieves; Servicio de Hematologia | Granada | 18014 | Spain |
| Hospital de Gran Canaria Dr. Negrin; Servicio de Hematologia | Las Palmas | 35020 | Spain |
| Hospital Universitario la Paz; Servicio de Hematologia | Madrid | 28046 | Spain |
| Hospital Universitario Puerta de Hierro; Servicio de Hematologia | Madrid | 28222 | Spain |
| Hospital Costa del Sol; Servicio de Hematologia | Málaga | 29600 | Spain |
| Hospital Universitario Virgen Macarena; Servicio de Hematologia | Seville | 41009 | Spain |
| Hospital Univ. Nuestra Señora de Valme; Servicio de Hematologia | Seville | 41014 | Spain |
| Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia | Valencia | 46010 | Spain |
| Hospital Universitario Dr. Peset; Servicio de Hematologia | Valencia | 46017 | Spain |
| Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia | Zaragoza | 50009 | Spain |
| COMPLETED |
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| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all participants, who received at least one dose of any treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Obinutuzumab + Bendamustine | Participants received obinutuzumab and bendamustine in 28-days cycles for a maximum of 6 cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Overall Response Rate (ORR) as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria | ORR was defined as percentage of participants achieving Complete Response (CR), incomplete CR (CRi) or Partial Response (PR). CR: lymphocytes below 4 x 10^9/L, absence of lymphadenopathy, hepatomegaly and splenomegaly, absence of disease or constitutional symptoms, neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 110 g/L, bone marrow at least normocellular for age. CRi: CR with persistent cytopenia, i.e. anemia, thrombocytopenia and/or neutropenia. PR: reduction ≥ 50% of the lymphocyte count AND reduction ≥ 50% of the lymphadenopathy OR reduction ≥ 50% of the size of the liver if enlarged at baseline OR reduction ≥ 50% of the size of the spleen if enlarged at baseline PLUS one of the following: neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 110 g/L or increase ≥ 50% compared to pre-treatment. | Efficacy population included all participants, who received at least one dose of both treatments (bendamustine and obinutuzumab). | Posted | Number | 95% Confidence Interval | percentage of participants | 2-3 months after last dose of the study treatment (up to approximately 9 months) |
|
|
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| Secondary | Best Response Rate as Assessed by the Investigator Using the IWCLL 2008 Criteria | Best overall response was defined as percentage of participants achieving a best response of CR, CRi and PR. CR: lymphocytes below 4 x 10^9/L, absence of lymphadenopathy, hepatomegaly and splenomegaly, absence of disease or constitutional symptoms, neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 110 g/L, bone marrow at least normocellular for age. CRi: CR with persistent cytopenia, i.e. anemia, thrombocytopenia and/or neutropenia. PR: reduction ≥ 50% of the lymphocyte count AND reduction ≥ 50% of the lymphadenopathy OR reduction ≥ 50% of the size of the liver if enlarged at baseline OR reduction ≥ 50% of the size of the spleen if enlarged at baseline PLUS one of the following: neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 110 g/L or increase ≥ 50% compared to pre-treatment. | Efficacy population included all participants, who received at least one dose of both treatments (bendamustine and obinutuzumab). Reported here is the number of participants for whom data for best response achieved were available. | Posted | Number | percentage of participants | During study treatment and until 6 months after end of study treatment at approximately 12 months |
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| Secondary | Progression Free Survival (PFS) | PFS is defined as the time from the start of treatment to disease progression (DP), relapse or death from any cause, whichever occurs first, as assessed by the investigator. DP: at least one of the following characteristics: increase ≥ 50% in lymphocytes up to at least 5 x 10^9/L, appearance of new palpable lymph nodes, increase ≥ 50% of the longest diameter of any previous area of clinically significant lymphadenopathy, increase ≥ 50% of the size of the liver and/or spleen, transformation to a more aggressive histology, after treatment progression of any cytopenia: decrease of hemoglobin levels of more than 20 g/L or to below 100 g/L and/or decrease of platelet counts by more than 50% or to below 100 x 10^9/L and/or decrease in the neutrophil counts by more than 50% or to below 1.0 x 10^9/L if the marrow biopsy also shows infiltration of clonal chronic lymphocytic leukemia (CLL) cells. | Efficacy population included all participants, who received at least one dose of both treatments (bendamustine and obinutuzumab). | Posted | Median | 95% Confidence Interval | months | From start of treatment up to disease progression or relapse or death, whichever occurred first (up to approximately 4.5 years) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the start of study treatment to death from any cause. | Efficacy population included all participants, who received at least one dose of both treatments (bendamustine and obinutuzumab). | Posted | Median | 95% Confidence Interval | months | From start of treatment up to death of any cause (up to approximately 4.5 years) |
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| Secondary | Event Free Survival (EFS) | EFS was defined as the time from the start of treatment to DP/relapse, death from any cause or start of a new anti-leukemia therapy. DP: at least one of the following characteristics: increase ≥ 50% in lymphocytes up to at least 5 x 10^9/L, appearance of new palpable lymph nodes, increase ≥ 50% of the longest diameter of any previous area of clinically significant lymphadenopathy, increase ≥ 50% of the size of the liver and/or spleen, transformation to a more aggressive histology, after treatment, progression of any cytopenia: decrease of hemoglobin levels of more than 20 g/L or to below 100 g/L and/or decrease of platelet counts by more than 50% or to below 100 x 10^9/L and/or decrease in the neutrophil counts by more than 50% or to below 1.0 x 10^9/L if the marrow biopsy also shows infiltration of clonal CLL cells. | Efficacy population included all participants, who received at least one dose of both treatments (bendamustine and obinutuzumab). | Posted | Median | 95% Confidence Interval | months | From start of treatment up to disease progression or relapse or death or start of a new anti-leukemic therapy, whichever occurred first (up to approximately 4.5 years) |
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| Secondary | Disease Free Survival (DFS) | DFS was defined for all participants who achieved complete response (CRi or CR). DFS lasted from the date on which CRi or CR was recorded until the date on which the first DP or death from any cause occurred. DP: at least one of the following characteristics: increase ≥ 50% in lymphocytes up to at least 5 x 10^9/L, appearance of new palpable lymph nodes, increase ≥ 50% of the longest diameter of any previous area of clinically significant lymphadenopathy, increase ≥ 50% of the size of the liver and/or spleen, transformation to a more aggressive histology, after treatment, progression of any cytopenia: decrease of hemoglobin levels of more than 20 g/L or to below 100 g/L and/or decrease of platelet counts by more than 50% or to below 100 x 10^9/L and/or decrease in the neutrophil counts by more than 50% or to below 1.0 x 10^9/L if the marrow biopsy also shows infiltration of clonal CLL cells. | Efficacy population included all participants, who received at least one dose of both treatments (bendamustine and obinutuzumab). Included in the analysis are participants who achieved CRi or CR. | Posted | Median | 95% Confidence Interval | months | From occurrence of complete response up to disease progression or death, whichever occurred first (up to approximately 4.5 years) |
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| Secondary | Duration of Response (DR) | DR was defined for participants with CRi, CR or PR. DR spanned from the date on which response was recorded until the date on which DP or death from any cause occurred. DP: at least one of the following characteristics: increase ≥ 50% in lymphocytes up to at least 5 x 10^9/L, appearance of new palpable lymph nodes, increase ≥ 50% of the longest diameter of any previous area of clinically significant lymphadenopathy, increase ≥ 50% of the size of the liver and/or spleen, transformation to a more aggressive histology, after treatment, progression of any cytopenia: decrease of hemoglobin levels of more than 20 g/L or to below 100 g/L and/or decrease of platelet counts by more than 50% or to below 100 x 10^9/L and/or decrease in the neutrophil counts by more than 50% or to below 1.0 x 10^9/L if the marrow biopsy also shows infiltration of clonal CLL cells. | Efficacy population included all participants, who received at least one dose of both treatments (bendamustine and obinutuzumab). Included in the analysis are participants who achieved CRi, CR or PR. | Posted | Median | 95% Confidence Interval | months | From occurrence of CR or PR up to disease progression or death, whichever occurred first (up to approximately 4.5 years) |
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| Secondary | Time to Re-treatment/New Anti-leukemia Therapy | Time to re-treatment/new leukemia therapy was defined as the time between the start of treatment and the date of the first administration of re-treatment or new leukemia therapy. | Efficacy population included all participants, who received at least one dose of both treatments (bendamustine and obinutuzumab). | Posted | Median | 95% Confidence Interval | months | Up to 4.5 years |
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| Secondary | Percentage of Participants With Minimal Residual Disease (MRD) Negativity | MRD negativity was defined as the presence of less than 1 cell of CLL per 10,000 leukocytes (= category 0, <0.01%) assessed in bone marrow (BM) and peripheral blood (PB) by flow cytometry after the end of the treatment at the final response assessment. | ITT population included all participants, who received at least one dose of any treatment. | Posted | Number | percentage of participants | At approximately 9 months |
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| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. An SAE was any AE that was any of the following: fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, and was considered a significant medical event by the investigator. | Safety population included all participants, who received at least one dose of any treatment. | Posted | Number | percentage of participants | Up to approximately 4.5 years |
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| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With AEs of Special Interest (AESIs) | AESIs included any of the following: SAEs associated with the infusion of obinutuzumab: obinutuzumab serious infusion-related reactions, which were defined as AEs occurring during or within 24 hours following the administration of an infusion of obinutuzumab and considered related to obinutuzumab; serious infection; serious neutropenia; any tumor lysis syndrome (TLS); second malignancies. | Safety population included all participants, who received at least one dose of any treatment. | Posted | Number | percentage of participants | Up to approximately 4.5 years |
|
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| Secondary | Percentage of Participants With Infusion-related Reactions (IRRs) | IRRs were defined as AEs occurring during or within 24 hours following the administration of an infusion and considered related to drug treatment. | Safety population included all participants, who received at least one dose of any treatment. | Posted | Number | percentage of participants | Up to end of treatment at 6 months |
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| Secondary | Percentage of Participants Who Discontinued Treatment Prematurely | Safety population included all participants, who received at least one dose of any treatment. | Posted | Number | percentage of participants | Up to end of treatment at 6 months |
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| Secondary | Percentage of Participants With Previous/Concomitant Diseases | Safety population included all participants, who received at least one dose of any treatment. | Posted | Number | percentage of participants | Up to approximately 4.5 years |
|
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| Secondary | Percentage of Participants With Concomitant Medication | Concomitant therapies included any medication (prescription medication, over-the-counter medications, herbal/homeopathic remedies, nutritional supplements) used by subjects in the 7 days prior to screening until the end of treatment. The following treatments were not permitted during the study treatment period: investigational or unauthorized or unapproved medicinal products, immunotherapy or radioimmunotherapy (other than the trial immunotherapy, obinutuzumab), chemotherapy (other than the trial chemotherapy, bendamustine) and radiotherapy. | Safety population included all participants, who received at least one dose of any treatment. | Posted | Number | percentage of participants | From 7 days prior to screening to the end of treatment at 6 months |
|
|
Up to approximately 4.5 years
Safety population included all participants, who received at least one dose of any treatment.
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 | Obinutuzumab + Bendamustine | Participants received obinutuzumab and bendamustine in 28-days cycles for a maximum of 6 cycles. | 25 | 72 | 37 | 72 | 67 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute myelomonocytic leukaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cachexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Rotavirus infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Serratia sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Glioblastoma multiforme | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Laryngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Bronchiolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chest pain | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.1 | 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-La Roche | 800 821-8590 | genentech@druginfo.com |
| Nov 6, 2019 |
| Prot_SAP_000.pdf |
| 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 |
| C543332 | obinutuzumab |
| 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 |
Not provided
Not provided
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