Back to resultsA Study Evaluating the Efficacy of Obinutuzumab and Bendamustine Treatment in Participants With Refractory or Relapsed Chronic Lymphocytic Leukemia
Primary Purpose
Chronic Lymphocytic Leukemia
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
bendamustine
obinutuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- Diagnosed CD20+ B- chronic lymphocytic leukemia (CLL) according to National Cancer Institute (NCI) criteria
- Active disease meeting at least 1 of the International Workshop on CLL (IWCLL) 2008 criteria for treatment
- Refractory CLL (i.e. treatment failure or progression during treatment or within 6 months after the last treatment) or relapse CLL (i.e. participants who met criteria for CR or PR, but progressed beyond 6 months post-treatment)
- At least 1 prior purine analogue or bendamustine containing therapy
- Life expectancy greater than (>) 6 months
- Use of effective contraception as described in the study protocol
Exclusion Criteria:
- Prior Alogenic Bone Marrow Transplant
- Greater than or equal to (>/=) 3 previous lines of chemotherapy and/or immunotherapy for the CLL
- Previous obinutuzumab-containing regimen
- Treatment failure or progression within 6 months of bendamustine-containing regimen
- Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL; Richter's transformation) Patients with prolymphocytic transformation cannot entry the study either
- Active haemolytic anaemia
- Inadequate liver function
- History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with a history of malignancy that has been treated but not with curative intent will be excluded, unless the malignancy has been in remission without treatment for >/= 2 years prior to enrolment. Patients with a history of adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent are eligible
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease
- Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
- Regular treatment with corticosteroids during the 4 weeks prior to study start, unless administered for another condition at a dose equivalent to less than or equal to (</=) 30 milligrams per day (mg/day) prednisone
- Known active infection or any infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to study start
- Patients with HIV, human T cell leukemia virus 1 (HTLV-1), hepatitis B or hepatitis C
- Pregnancy or breast-feeding
- Vaccination with a live vaccine within 4 weeks prior to baseline visit
- Receipt of any other study drug within 4 weeks prior to study start
Sites / Locations
- Hospital De Txagorritxu; Servicio de Hematologia
- Hospital General Universitario de Elche; Servicio de Hematologia
- Hospital de Cabueñes; Servicio de Hematología y Hemoterapia
- Hospital Univ. Central de Asturias; servicio de Hematologia
- Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
- Hospital Mutua de Terrassa; Servicio de Hematologia
- Hospital de Navarra, Servicio de Hematología
- Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Hematologia
- Hospital Universitari Vall d'Hebron; Servicio de Hematologia
- Hospital Clínic i Provincial; Servicio de Hematología y Oncología
- Hospital General de Castellon; Servicio de Hematologia
- Hospital Universitario Virgen de las Nieves; Servicio de Hematologia
- Hospital de Gran Canaria Dr. Negrin; Servicio de Hematologia
- Hospital Universitario la Paz; Servicio de Hematologia
- Hospital Universitario Puerta de Hierro; Servicio de Hematologia
- Hospital Costa del Sol; Servicio de Hematologia
- Hospital Universitario Virgen Macarena; Servicio de Hematologia
- Hospital Univ. Nuestra Señora de Valme; Servicio de Hematologia
- Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
- Hospital Universitario Dr. Peset; Servicio de Hematologia
- Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Obinutuzmab + Bendamustine
Arm Description
Participants will receive obinutuzumab and bendamustine in 28-days cycles for a maximum of 6 cycles
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Overall Survival (OS)
OS was defined as the time from the start of study treatment to death from any cause.
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.
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.
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.
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.
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.
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.
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.
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.
Percentage of Participants Who Discontinued Treatment Prematurely
Percentage of Participants With Previous/Concomitant Diseases
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02071225
Brief Title
A Study Evaluating the Efficacy of Obinutuzumab and Bendamustine Treatment in Participants With Refractory or Relapsed Chronic Lymphocytic Leukemia
Official Title
Phase II Trial to Evaluate The Efficacy of Obinutuzumab (RO5072759) + Bendamustine Treatment in Patients With Refractory Or Relapsed Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 9, 2014 (Actual)
Primary Completion Date
November 19, 2018 (Actual)
Study Completion Date
November 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obinutuzmab + Bendamustine
Arm Type
Experimental
Arm Description
Participants will receive obinutuzumab and bendamustine in 28-days cycles for a maximum of 6 cycles
Intervention Type
Drug
Intervention Name(s)
bendamustine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
obinutuzumab
Other Intervention Name(s)
RO5072759
Intervention Description
1000 mg given by IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of subsequent cycles.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria
Description
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.
Time Frame
2-3 months after last dose of the study treatment (up to approximately 9 months)
Secondary Outcome Measure Information:
Title
Best Response Rate as Assessed by the Investigator Using the IWCLL 2008 Criteria
Description
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.
Time Frame
During study treatment and until 6 months after end of study treatment at approximately 12 months
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
From start of treatment up to disease progression or relapse or death, whichever occurred first (up to approximately 4.5 years)
Title
Overall Survival (OS)
Description
OS was defined as the time from the start of study treatment to death from any cause.
Time Frame
From start of treatment up to death of any cause (up to approximately 4.5 years)
Title
Event Free Survival (EFS)
Description
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.
Time Frame
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)
Title
Disease Free Survival (DFS)
Description
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.
Time Frame
From occurrence of complete response up to disease progression or death, whichever occurred first (up to approximately 4.5 years)
Title
Duration of Response (DR)
Description
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.
Time Frame
From occurrence of CR or PR up to disease progression or death, whichever occurred first (up to approximately 4.5 years)
Title
Time to Re-treatment/New Anti-leukemia Therapy
Description
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.
Time Frame
Up to 4.5 years
Title
Percentage of Participants With Minimal Residual Disease (MRD) Negativity
Description
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.
Time Frame
At approximately 9 months
Title
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to approximately 4.5 years
Title
Percentage of Participants With AEs of Special Interest (AESIs)
Description
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.
Time Frame
Up to approximately 4.5 years
Title
Percentage of Participants With Infusion-related Reactions (IRRs)
Description
IRRs were defined as AEs occurring during or within 24 hours following the administration of an infusion and considered related to drug treatment.
Time Frame
Up to end of treatment at 6 months
Title
Percentage of Participants Who Discontinued Treatment Prematurely
Time Frame
Up to end of treatment at 6 months
Title
Percentage of Participants With Previous/Concomitant Diseases
Time Frame
Up to approximately 4.5 years
Title
Percentage of Participants With Concomitant Medication
Description
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.
Time Frame
From 7 days prior to screening to the end of treatment at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
Diagnosed CD20+ B- chronic lymphocytic leukemia (CLL) according to National Cancer Institute (NCI) criteria
Active disease meeting at least 1 of the International Workshop on CLL (IWCLL) 2008 criteria for treatment
Refractory CLL (i.e. treatment failure or progression during treatment or within 6 months after the last treatment) or relapse CLL (i.e. participants who met criteria for CR or PR, but progressed beyond 6 months post-treatment)
At least 1 prior purine analogue or bendamustine containing therapy
Life expectancy greater than (>) 6 months
Use of effective contraception as described in the study protocol
Exclusion Criteria:
Prior Alogenic Bone Marrow Transplant
Greater than or equal to (>/=) 3 previous lines of chemotherapy and/or immunotherapy for the CLL
Previous obinutuzumab-containing regimen
Treatment failure or progression within 6 months of bendamustine-containing regimen
Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL; Richter's transformation) Patients with prolymphocytic transformation cannot entry the study either
Active haemolytic anaemia
Inadequate liver function
History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with a history of malignancy that has been treated but not with curative intent will be excluded, unless the malignancy has been in remission without treatment for >/= 2 years prior to enrolment. Patients with a history of adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent are eligible
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease
Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
Regular treatment with corticosteroids during the 4 weeks prior to study start, unless administered for another condition at a dose equivalent to less than or equal to (</=) 30 milligrams per day (mg/day) prednisone
Known active infection or any infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to study start
Patients with HIV, human T cell leukemia virus 1 (HTLV-1), hepatitis B or hepatitis C
Pregnancy or breast-feeding
Vaccination with a live vaccine within 4 weeks prior to baseline visit
Receipt of any other study drug within 4 weeks prior to study start
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Hospital De Txagorritxu; Servicio de Hematologia
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01009
Country
Spain
Facility Name
Hospital General Universitario de Elche; Servicio de Hematologia
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital de Cabueñes; Servicio de Hematología y Hemoterapia
City
Gijon
State/Province
Asturias
ZIP/Postal Code
33203
Country
Spain
Facility Name
Hospital Univ. Central de Asturias; servicio de Hematologia
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08915
Country
Spain
Facility Name
Hospital Mutua de Terrassa; Servicio de Hematologia
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital de Navarra, Servicio de Hematología
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Hematologia
City
Santa Cruz de Tenerife
State/Province
Tenerife
ZIP/Postal Code
38010
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General de Castellon; Servicio de Hematologia
City
Castellon
ZIP/Postal Code
12004
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves; Servicio de Hematologia
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital de Gran Canaria Dr. Negrin; Servicio de Hematologia
City
Las Palmas
ZIP/Postal Code
35020
Country
Spain
Facility Name
Hospital Universitario la Paz; Servicio de Hematologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro; Servicio de Hematologia
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Costa del Sol; Servicio de Hematologia
City
Malaga
ZIP/Postal Code
29600
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Hematologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Univ. Nuestra Señora de Valme; Servicio de Hematologia
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario Dr. Peset; Servicio de Hematologia
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating the Efficacy of Obinutuzumab and Bendamustine Treatment in Participants With Refractory or Relapsed Chronic Lymphocytic Leukemia
We'll reach out to this number within 24 hrs