Back to resultsCLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)
Primary Purpose
Lymphocytic Leukemia, Chronic
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
obinutuzumab
rituximab
chlorambucil
Sponsored by
About this trial
This is an interventional treatment trial for Lymphocytic Leukemia, Chronic
Eligibility Criteria
Inclusion Criteria:
- Adults >/=18 years
- Documented Cluster of Differentiation Antigen 20 (CD20) + B-Cell Chronic Lymphocytic Lymphoma (B-CLL)
- Previously untreated Chronic Lymphocytic Leukemia (CLL) requiring treatment according to the National Cancer Institute (NCI) criteria
- Total Cumulative Illness Rating Scale (CIRS) > 6 and/or creatinine clearance < 70 ml/min.
Exclusion Criteria:
- Prior CLL therapy
- Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
- History of other malignancy unless the malignancy has been in remission without treatment for >/=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone
- Positive hepatitis serology (HBV, HCV) or positive HIV or Human T-Cell Leukemia Virus (HTLV) testing
- Patients with active infection requiring systemic treatment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
obinutuzumab + chlorambucil (GClb)
rituximab + chlorambucil (RClb)
Chlorambucil (Clb)
Arm Description
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS)
PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).
Percentage of Participants With Progression Free Survival Events
Percentage of Participants with Progression Free Survival Events: progression, relapse, or death.
Secondary Outcome Measures
Progression Free Survival Based on Independent Review Committee (IRC) Data
PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by Independent Review Committee. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).
Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data
Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.
Percentage of Participants With End of Treatment Response (EOTR)
EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. Complete Response (CR) required: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. Partial Response (PR) required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.
Percentage of Participants With Best Overall Response
Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi, PR or nodular Partial Response (nPR). CR required all of the following: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.
Event Free Survival
Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).
Overall Survival
Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.
Duration of Response
Duration of Response was defined as the date the response [either Complete Response (CR) or Partial Response (PR)] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines.
Percentage of Participants With Molecular Remission at the End of Treatment
Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 chronic lymphocytic leukemia (CLL) cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).
Time to Re-Treatment/New Anti-leukemic Therapy
Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy.
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
The EORTC Quality of Life Questionnaire (QLQ-C30) was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire
EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.
Full Information
NCT ID
NCT02053610
First Posted
November 25, 2013
Last Updated
August 15, 2018
Sponsor
Hoffmann-La Roche
Collaborators
German CLL Study Group, Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02053610
Brief Title
CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)
Official Title
An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 31, 2009 (Actual)
Primary Completion Date
August 31, 2013 (Actual)
Study Completion Date
August 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
German CLL Study Group, Genentech, Inc.
4. Oversight
5. Study Description
Brief Summary
This open-label, randomized, 3-arm study will evaluate the efficacy and safety of (obinutuzumab) RO5072759 in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.
Detailed Description
Protocol BO21004 is divided into 3 separate Unique Protocol IDs for reporting results on clinicaltrials.gov because there are 3 separate primary analyses conducted at different time-points.
BO21004 (Stage 1a) [NCT01010061] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to chlorambucil (Clb) reported separately.
BO21004 (Stage 1b) [NCT01998880] includes the analysis of 2 of the 3 arms rituximab plus chlorambucil (RClb) compared to chlorambucil (Clb) reported separately.
BO21004 (Stage 2) includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to rituximab plus chlorambucil (RClb) reported here.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphocytic Leukemia, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
787 (Actual)
8. Arms, Groups, and Interventions
Arm Title
obinutuzumab + chlorambucil (GClb)
Arm Type
Experimental
Arm Description
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
Arm Title
rituximab + chlorambucil (RClb)
Arm Type
Active Comparator
Arm Description
Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
Arm Title
Chlorambucil (Clb)
Arm Type
Active Comparator
Arm Description
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
Intervention Type
Drug
Intervention Name(s)
obinutuzumab
Other Intervention Name(s)
RO5072759, GA101, GAZYVA®, Gazyvaro
Intervention Description
1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles).
Intervention Type
Drug
Intervention Name(s)
rituximab
Other Intervention Name(s)
Rituxan®, MabThera®
Intervention Description
375 mg/m^2 rituximab intravenous (IV) infusion on Day 1 of Cycle 1 (Cycle duration is 28 days) then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6.
Intervention Type
Drug
Intervention Name(s)
chlorambucil
Intervention Description
Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).
Time Frame
Randomization to clinical cutoff (median observation 59.4 months)
Title
Percentage of Participants With Progression Free Survival Events
Description
Percentage of Participants with Progression Free Survival Events: progression, relapse, or death.
Time Frame
Randomization to clinical cutoff (median observation 59.4 months)
Secondary Outcome Measure Information:
Title
Progression Free Survival Based on Independent Review Committee (IRC) Data
Description
PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by Independent Review Committee. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).
Time Frame
Randomization to clinical cutoff of 09 May 2013 (median observation 18.7 months)
Title
Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data
Description
Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.
Time Frame
Randomization to clinical cutoff of 09 May 2013 (median observation 18.7 months)
Title
Percentage of Participants With End of Treatment Response (EOTR)
Description
EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. Complete Response (CR) required: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. Partial Response (PR) required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.
Time Frame
Randomization to clinical cutoff (median observation 59.4 months)
Title
Percentage of Participants With Best Overall Response
Description
Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi, PR or nodular Partial Response (nPR). CR required all of the following: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.
Time Frame
Randomization to clinical cutoff (median observation 59.4 months)
Title
Event Free Survival
Description
Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).
Time Frame
Randomization to clinical cutoff (median observation 59.4 months)
Title
Overall Survival
Description
Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.
Time Frame
Randomization to clinical cutoff (median observation 59.4 months)
Title
Duration of Response
Description
Duration of Response was defined as the date the response [either Complete Response (CR) or Partial Response (PR)] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines.
Time Frame
Randomization to clinical cutoff (median observation 59.4 months)
Title
Percentage of Participants With Molecular Remission at the End of Treatment
Description
Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 chronic lymphocytic leukemia (CLL) cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).
Time Frame
Randomization to clinical cutoff (median observation 59.4 months)
Title
Time to Re-Treatment/New Anti-leukemic Therapy
Description
Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy.
Time Frame
Randomization to clinical cutoff (median observation 59.4 months)
Title
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
Description
The EORTC Quality of Life Questionnaire (QLQ-C30) was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.
Time Frame
Baseline and Cycle 4 Day 1 (Cy4D1)
Title
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire
Description
EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.
Time Frame
Baseline and Cycle 4 Day 1 (Cy4D1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults >/=18 years
Documented Cluster of Differentiation Antigen 20 (CD20) + B-Cell Chronic Lymphocytic Lymphoma (B-CLL)
Previously untreated Chronic Lymphocytic Leukemia (CLL) requiring treatment according to the National Cancer Institute (NCI) criteria
Total Cumulative Illness Rating Scale (CIRS) > 6 and/or creatinine clearance < 70 ml/min.
Exclusion Criteria:
Prior CLL therapy
Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
History of other malignancy unless the malignancy has been in remission without treatment for >/=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone
Positive hepatitis serology (HBV, HCV) or positive HIV or Human T-Cell Leukemia Virus (HTLV) testing
Patients with active infection requiring systemic treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
City
Buenos Aires
ZIP/Postal Code
1406
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1114AAN
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1180AAX
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1221ADC
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
City
Adelaide
State/Province
New South Wales
ZIP/Postal Code
5011
Country
Australia
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
City
Graz
ZIP/Postal Code
8036
Country
Austria
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Wien
ZIP/Postal Code
1160
Country
Austria
City
Goiania
State/Province
GO
ZIP/Postal Code
74140-050
Country
Brazil
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
31270-901
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90880-480
Country
Brazil
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R0C 2Z0
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
City
København
ZIP/Postal Code
2100
Country
Denmark
City
Odense
ZIP/Postal Code
5000
Country
Denmark
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
City
Århus
ZIP/Postal Code
8000
Country
Denmark
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
City
Angers
ZIP/Postal Code
49933
Country
France
City
Bobigny
ZIP/Postal Code
93009
Country
France
City
Caen
ZIP/Postal Code
14076
Country
France
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
City
Creteil
ZIP/Postal Code
94010
Country
France
City
Le Mans
ZIP/Postal Code
72015
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
Lyon
ZIP/Postal Code
69373
Country
France
City
Marseille
ZIP/Postal Code
13273
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Nantes
ZIP/Postal Code
44093
Country
France
City
Paris
ZIP/Postal Code
75475
Country
France
City
Paris
ZIP/Postal Code
75651
Country
France
City
Pessac
ZIP/Postal Code
33604
Country
France
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
City
Poitiers
ZIP/Postal Code
86021
Country
France
City
Reims
ZIP/Postal Code
51092
Country
France
City
Rennes
ZIP/Postal Code
35033
Country
France
City
Rouen
ZIP/Postal Code
76038
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Tours
ZIP/Postal Code
37044
Country
France
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
City
Ahaus
ZIP/Postal Code
48683
Country
Germany
City
Amberg
ZIP/Postal Code
92224
Country
Germany
City
Ansbach
ZIP/Postal Code
91522
Country
Germany
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Bonn
ZIP/Postal Code
53113
Country
Germany
City
Bremen
ZIP/Postal Code
28177
Country
Germany
City
Bremen
ZIP/Postal Code
28209
Country
Germany
City
Bremen
ZIP/Postal Code
28239
Country
Germany
City
Delitzsch
ZIP/Postal Code
04509
Country
Germany
City
Detmold
ZIP/Postal Code
32756
Country
Germany
City
Dresden
ZIP/Postal Code
01127
Country
Germany
City
Dresden
ZIP/Postal Code
01307
Country
Germany
City
Duisburg
ZIP/Postal Code
47051
Country
Germany
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
City
Eschweiler
ZIP/Postal Code
52249
Country
Germany
City
Essen
ZIP/Postal Code
45122
Country
Germany
City
Essen
ZIP/Postal Code
45239
Country
Germany
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
City
Frankfurt am Main
ZIP/Postal Code
60389
Country
Germany
City
Frankfurt an der Oder
ZIP/Postal Code
15236
Country
Germany
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
City
Frechen
ZIP/Postal Code
50226
Country
Germany
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
City
Giessen
Country
Germany
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
City
Hamburg
ZIP/Postal Code
22087
Country
Germany
City
Hamburg
ZIP/Postal Code
22767
Country
Germany
City
Hamm
ZIP/Postal Code
59063
Country
Germany
City
Hannover
ZIP/Postal Code
30449
Country
Germany
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
City
Homburg/Saar
ZIP/Postal Code
66241
Country
Germany
City
Kaiserslautern
ZIP/Postal Code
67655
Country
Germany
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
City
Kempten
ZIP/Postal Code
87439
Country
Germany
City
Kiel
ZIP/Postal Code
24116
Country
Germany
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
City
Koeln
ZIP/Postal Code
50674
Country
Germany
City
Kronach
ZIP/Postal Code
96317
Country
Germany
City
Köln
ZIP/Postal Code
50924
Country
Germany
City
Landshut
ZIP/Postal Code
84028
Country
Germany
City
Lebach
ZIP/Postal Code
66822
Country
Germany
City
Leer
ZIP/Postal Code
26789
Country
Germany
City
Lemgo
ZIP/Postal Code
32657
Country
Germany
City
Lörrach
ZIP/Postal Code
79539
Country
Germany
City
Lüdenscheid
ZIP/Postal Code
58515
Country
Germany
City
Magedburg
ZIP/Postal Code
39104
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Mannheim
ZIP/Postal Code
68161
Country
Germany
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
City
Mutlangen
ZIP/Postal Code
73557
Country
Germany
City
München
ZIP/Postal Code
80335
Country
Germany
City
München
ZIP/Postal Code
81241
Country
Germany
City
München
ZIP/Postal Code
81479
Country
Germany
City
München
ZIP/Postal Code
81675
Country
Germany
City
Neunkirchen/Saar
ZIP/Postal Code
66538
Country
Germany
City
Nürnberg
ZIP/Postal Code
90449
Country
Germany
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
City
Porta Westfalica
ZIP/Postal Code
32457
Country
Germany
City
Ravensburg
ZIP/Postal Code
88212
Country
Germany
City
Recklinghausen
ZIP/Postal Code
45657
Country
Germany
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
City
Rostock
ZIP/Postal Code
18057
Country
Germany
City
Rüsselsheim
ZIP/Postal Code
65428
Country
Germany
City
Saarbruecken
ZIP/Postal Code
66113
Country
Germany
City
Sindelfingen
ZIP/Postal Code
71065
Country
Germany
City
Stuttgart
ZIP/Postal Code
70199
Country
Germany
City
Trier
ZIP/Postal Code
54290
Country
Germany
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
City
Ulm
ZIP/Postal Code
89081
Country
Germany
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
City
Weilheim
ZIP/Postal Code
82362
Country
Germany
City
Wendlingen
ZIP/Postal Code
73240
Country
Germany
City
Witten
ZIP/Postal Code
58452
Country
Germany
City
Worms
ZIP/Postal Code
67547
Country
Germany
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
City
Hong Kong
Country
Hong Kong
City
Cosenza
State/Province
Calabria
ZIP/Postal Code
87100
Country
Italy
City
Ferrara
State/Province
Emilia-Romagna
ZIP/Postal Code
44100
Country
Italy
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41100
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
City
Orbassano
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09121
Country
Italy
City
Messina
State/Province
Sicilia
ZIP/Postal Code
98165
Country
Italy
City
Terni
State/Province
Umbria
ZIP/Postal Code
05100
Country
Italy
City
Aguascalientes
ZIP/Postal Code
20127
Country
Mexico
City
Culiacan
ZIP/Postal Code
80230
Country
Mexico
City
Hermosillo
ZIP/Postal Code
83000
Country
Mexico
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
City
San Luis Potosi
ZIP/Postal Code
78218
Country
Mexico
City
Delftzijl
ZIP/Postal Code
9934 JD
Country
Netherlands
City
Enschede
ZIP/Postal Code
7511 JX
Country
Netherlands
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
City
Nieuwegein
ZIP/Postal Code
3430 EM
Country
Netherlands
City
Auckland
ZIP/Postal Code
1009
Country
New Zealand
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
City
Bucuresti
ZIP/Postal Code
030171
Country
Romania
City
Targu-mures
ZIP/Postal Code
540136
Country
Romania
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
City
Penza
ZIP/Postal Code
440071
Country
Russian Federation
City
Perm
ZIP/Postal Code
614077
Country
Russian Federation
City
Rostov-na-donu
ZIP/Postal Code
344022
Country
Russian Federation
City
UFA
ZIP/Postal Code
450005
Country
Russian Federation
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08240
Country
Spain
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
City
Jerez de La Frontera
State/Province
Cadiz
ZIP/Postal Code
11407
Country
Spain
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
City
La Coruna
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
City
Gandia
State/Province
Valencia
ZIP/Postal Code
46702
Country
Spain
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Jaen
ZIP/Postal Code
23007
Country
Spain
City
Las Palmas
ZIP/Postal Code
35020
Country
Spain
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Madrid
ZIP/Postal Code
28031
Country
Spain
City
Madrid
ZIP/Postal Code
28033
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Madrid
ZIP/Postal Code
28222
Country
Spain
City
Madrid
ZIP/Postal Code
28905
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Malaga
ZIP/Postal Code
29600
Country
Spain
City
Murcia
ZIP/Postal Code
30008
Country
Spain
City
Murcia
ZIP/Postal Code
30120
Country
Spain
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
City
Toledo
ZIP/Postal Code
45004
Country
Spain
City
Toledo
ZIP/Postal Code
45600
Country
Spain
City
Valencia
ZIP/Postal Code
46009
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Valencia
ZIP/Postal Code
46014
Country
Spain
City
Valencia
ZIP/Postal Code
46015
Country
Spain
City
Valencia
ZIP/Postal Code
46017
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
City
Canterbury
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
City
Cardiff
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
City
Cottingham
ZIP/Postal Code
HU16 5JG
Country
United Kingdom
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29255066
Citation
Dimier N, Delmar P, Ward C, Morariu-Zamfir R, Fingerle-Rowson G, Bahlo J, Fischer K, Eichhorst B, Goede V, van Dongen JJM, Ritgen M, Bottcher S, Langerak AW, Kneba M, Hallek M. A model for predicting effect of treatment on progression-free survival using MRD as a surrogate end point in CLL. Blood. 2018 Mar 1;131(9):955-962. doi: 10.1182/blood-2017-06-792333. Epub 2017 Dec 18.
Results Reference
derived
Learn more about this trial
CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)
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