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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01010061




Trial ID
NCT01010061
Ethics application status
Date submitted
6/11/2009
Date registered
6/11/2009
Date last updated
15/08/2018

Titles & IDs
Public title
CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)
Scientific 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.
Secondary ID [1] 0 0
2009-012476-28; CLL11
Secondary ID [2] 0 0
BO21004 (Stage 1a)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphocytic Leukemia, Chronic 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - obinutuzumab
Treatment: Drugs - rituximab
Treatment: Drugs - chlorambucil

Experimental: obinutuzumab + chlorambucil (GClb) - 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).

Active Comparator: rituximab + chlorambucil (RClb) - 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).

Active Comparator: Chlorambucil (Clb) - 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.


Treatment: Drugs: obinutuzumab
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).

Treatment: Drugs: rituximab
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.

Treatment: Drugs: chlorambucil
Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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 (PD) 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).
Timepoint [1] 0 0
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
Primary outcome [2] 0 0
Percentage of Participants With Progression Free Survival Events - Percentage of Participants with Progression Free Survival Events: disease progression, relapse, or death.
Timepoint [2] 0 0
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
Secondary outcome [1] 0 0
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).
Timepoint [1] 0 0
Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months)
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months)
Secondary outcome [3] 0 0
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. 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. 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.
Timepoint [3] 0 0
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
Secondary outcome [4] 0 0
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 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.
Timepoint [4] 0 0
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
Secondary outcome [5] 0 0
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).
Timepoint [5] 0 0
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
Secondary outcome [6] 0 0
Overall Survival - Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.
Timepoint [6] 0 0
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
Secondary outcome [8] 0 0
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).
Timepoint [8] 0 0
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
Secondary outcome [9] 0 0
Time to Re-Treatment/New-antileukemic 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.
Timepoint [9] 0 0
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
Secondary outcome [10] 0 0
Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb) - Blood samples were collected from all patients allocated to the GClb treatment arm pre- and post-dose Day 1 of Cycles 1 to 6 and were sent to a laboratory. The concentration of obinutzumab in serum was determined using a validated enzyme-linked immunosorbent assay (ELISA) and was reported in micrograms/milliliter (µg/mL).
Timepoint [10] 0 0
Pre- and post-dose sampling on day 1 of cycles 1-6 (Up to 26.8 months)
Secondary outcome [11] 0 0
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score - 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.
Timepoint [11] 0 0
Baseline and Cycle 4 Day 1 (Cy4D1)
Secondary outcome [12] 0 0
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score - 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.
Timepoint [12] 0 0
Baseline and Cycle 4 Day 1 (Cy4D1)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 lymphectomy
alone

- Positive hepatitis serology (HBV, HCV) or positive HIV or Human T Cell Leukemia Virus
(HTLV) testing

- Patients with active infection requiring systemic treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Gosford
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Liverpool
Recruitment hospital [5] 0 0
- St. Leonards
Recruitment hospital [6] 0 0
- Sydney
Recruitment hospital [7] 0 0
- Greenslopes
Recruitment hospital [8] 0 0
- Southport
Recruitment hospital [9] 0 0
- Woolloongabba
Recruitment hospital [10] 0 0
- Kurralta Park
Recruitment hospital [11] 0 0
- Frankston
Recruitment hospital [12] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2065 - St. Leonards
Recruitment postcode(s) [6] 0 0
2139 - Sydney
Recruitment postcode(s) [7] 0 0
4120 - Greenslopes
Recruitment postcode(s) [8] 0 0
4215 - Southport
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [11] 0 0
3199 - Frankston
Recruitment postcode(s) [12] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Illinois
Country [3] 0 0
United States of America
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Maryland
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Rosario
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Wien
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Brazil
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GO
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Brazil
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MG
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Brazil
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RS
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Brazil
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SP
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Bulgaria
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Vratsa
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Canada
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Alberta
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Canada
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Manitoba
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Croatia
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Zagreb
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Praha 2
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Denmark
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Aalborg
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Denmark
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København
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Denmark
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Odense
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Denmark
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Vejle
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Denmark
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Århus
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Egypt
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Cairo
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Estonia
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Tallinn
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Estonia
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Tartu
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France
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Angers
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Bobigny
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Caen
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Clermont Ferrand
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France
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Creteil
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France
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Le Mans
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France
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Lille
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Lyon
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France
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Marseille
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Montpellier
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Nantes
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Paris
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Pessac
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France
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Pierre Benite
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Poitiers
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Reims
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Rennes
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Rouen
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Toulouse
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Tours
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Vandoeuvre Les Nancy
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Germany
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Ahaus
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Germany
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Amberg
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Germany
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Ansbach
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Germany
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Bamberg
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Bremen
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Germany
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Delitzsch
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Germany
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Detmold
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Germany
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Dresden
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Germany
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Duisburg
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Germany
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Erlangen
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Germany
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Eschweiler
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Germany
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Essen
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Germany
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Esslingen
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Germany
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Frankfurt am Main
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Germany
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Frankfurt an der Oder
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Germany
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Frankfurt
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Germany
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Frechen
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Germany
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Freiburg
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Germany
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Giessen
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Germany
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Greifswald
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Germany
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Göttingen
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Germany
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Hamburg
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Germany
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Hamm
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Homburg/Saar
Country [85] 0 0
Germany
State/province [85] 0 0
Kaiserslautern
Country [86] 0 0
Germany
State/province [86] 0 0
Karlsruhe
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Germany
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Kempten
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Germany
State/province [88] 0 0
Kiel
Country [89] 0 0
Germany
State/province [89] 0 0
Koblenz
Country [90] 0 0
Germany
State/province [90] 0 0
Koeln
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Germany
State/province [91] 0 0
Kronach
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Germany
State/province [92] 0 0
Köln
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Germany
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Landshut
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Germany
State/province [94] 0 0
Lebach
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Germany
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Leer
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Germany
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Lemgo
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Germany
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Lörrach
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Germany
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Lüdenscheid
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Germany
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Magedburg
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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Muenchen
Country [103] 0 0
Germany
State/province [103] 0 0
Mutlangen
Country [104] 0 0
Germany
State/province [104] 0 0
München
Country [105] 0 0
Germany
State/province [105] 0 0
Neunkirchen/Saar
Country [106] 0 0
Germany
State/province [106] 0 0
Nürnberg
Country [107] 0 0
Germany
State/province [107] 0 0
Oldenburg
Country [108] 0 0
Germany
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Porta Westfalica
Country [109] 0 0
Germany
State/province [109] 0 0
Ravensburg
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Germany
State/province [110] 0 0
Recklinghausen
Country [111] 0 0
Germany
State/province [111] 0 0
Regensburg
Country [112] 0 0
Germany
State/province [112] 0 0
Rostock
Country [113] 0 0
Germany
State/province [113] 0 0
Rüsselsheim
Country [114] 0 0
Germany
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Saarbruecken
Country [115] 0 0
Germany
State/province [115] 0 0
Sindelfingen
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Germany
State/province [116] 0 0
Stuttgart
Country [117] 0 0
Germany
State/province [117] 0 0
Trier
Country [118] 0 0
Germany
State/province [118] 0 0
Tübingen
Country [119] 0 0
Germany
State/province [119] 0 0
Ulm
Country [120] 0 0
Germany
State/province [120] 0 0
Villingen-Schwenningen
Country [121] 0 0
Germany
State/province [121] 0 0
Weilheim
Country [122] 0 0
Germany
State/province [122] 0 0
Wendlingen
Country [123] 0 0
Germany
State/province [123] 0 0
Witten
Country [124] 0 0
Germany
State/province [124] 0 0
Worms
Country [125] 0 0
Germany
State/province [125] 0 0
Wuerzburg
Country [126] 0 0
Germany
State/province [126] 0 0
Würzburg
Country [127] 0 0
Hong Kong
State/province [127] 0 0
Hong Kong
Country [128] 0 0
Italy
State/province [128] 0 0
Cagliari
Country [129] 0 0
Italy
State/province [129] 0 0
Cosenza
Country [130] 0 0
Italy
State/province [130] 0 0
Ferrara
Country [131] 0 0
Italy
State/province [131] 0 0
Genova
Country [132] 0 0
Italy
State/province [132] 0 0
Messina
Country [133] 0 0
Italy
State/province [133] 0 0
Milano
Country [134] 0 0
Italy
State/province [134] 0 0
Modena
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
German CLL Study Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Genentech, Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01010061
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries