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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01998880
Registration number
NCT01998880
Ethics application status
Date submitted
25/11/2013
Date registered
2/12/2013
Date last updated
14/09/2018
Titles & IDs
Public title
CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b)
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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
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Secondary ID [1]
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2009-012476-28; CLL1
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Secondary ID [2]
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BO21004 (Stage 1b)
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphocytic Leukemia, Chronic
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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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).
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Timepoint [1]
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Randomization to clinical cutoff (median observation 57.7 months)
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Primary outcome [2]
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Percentage of Participants With Progression Free Survival Events
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Assessment method [2]
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Percentage of Participants with Progression Free Survival Events: progression, relapse, or death.
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Timepoint [2]
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Randomization to clinical cutoff (median observation 57.7 months)
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Secondary outcome [1]
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Event Free Survival
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Assessment method [1]
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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 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).
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Timepoint [1]
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Randomization to clinical cutoff (median observation 57.7 months)
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Secondary outcome [2]
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Overall Survival
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Assessment method [2]
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Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.
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Timepoint [2]
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Randomization to clinical cutoff (median observation 57.7 months)
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Secondary outcome [3]
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Percentage of Participants With End of Treatment Response (EOTR)
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Assessment method [3]
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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.
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Timepoint [3]
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Randomization to clinical cutoff (median observation 57.7 months)
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Secondary outcome [4]
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Percentage of Participants With Molecular Remission at the End of Treatment
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Assessment method [4]
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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 CLL cell in 10000 leukocytes (MRD value \< 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).
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Timepoint [4]
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Randomization to clinical cutoff (median observation 57.7 months)
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Secondary outcome [5]
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Progression Free Survival Based on Independent Review Committee (IRC) Data
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Assessment method [5]
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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).
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Timepoint [5]
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Randomization to clinical cutoff date of 9 May 2013 (median observation 22.7 months)
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Secondary outcome [6]
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Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data
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Assessment method [6]
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Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.
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Timepoint [6]
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Randomization to clinical cutoff date of 9 May 2013 (median observation 22.7 months)
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Secondary outcome [7]
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European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline and Cycle 4 Day 1 (Cy4D1)
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Secondary outcome [8]
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European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline and Cycle 4 Day 1 (Cy4D1)
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Secondary outcome [9]
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Time to Re-Treatment/New-antileukemic Therapy
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Assessment method [9]
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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.
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Timepoint [9]
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Randomization to clinical cutoff (median observation 57.7 months)
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Secondary outcome [10]
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Duration of Response
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Assessment method [10]
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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.
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Timepoint [10]
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Randomization to clinical cutoff (median observation 57.7 months)
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Secondary outcome [11]
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Percentage of Participants With Best Overall Response
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Assessment method [11]
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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.
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Timepoint [11]
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Randomization to clinical cutoff (median observation 57.7 months)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/12/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/08/2017
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Sample size
Target
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Accrual to date
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Final
787
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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- Adelaide
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Recruitment hospital [2]
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- Gosford
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Recruitment hospital [3]
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- Kogarah
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- Liverpool
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Recruitment hospital [5]
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- St. Leonards
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Recruitment hospital [6]
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- Sydney
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Recruitment hospital [7]
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- Greenslopes
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Recruitment hospital [8]
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- Southport
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Recruitment hospital [9]
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- Woolloongabba
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Recruitment hospital [10]
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- Kurralta Park
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Recruitment hospital [11]
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- Frankston
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Recruitment hospital [12]
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- Melbourne
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Recruitment postcode(s) [1]
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5011 - Adelaide
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Recruitment postcode(s) [2]
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2250 - Gosford
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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2170 - Liverpool
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Recruitment postcode(s) [5]
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2065 - St. Leonards
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Recruitment postcode(s) [6]
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2139 - Sydney
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Recruitment postcode(s) [7]
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4120 - Greenslopes
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Recruitment postcode(s) [8]
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4215 - Southport
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Recruitment postcode(s) [9]
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4102 - Woolloongabba
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Recruitment postcode(s) [10]
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5037 - Kurralta Park
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Recruitment postcode(s) [11]
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3199 - Frankston
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Recruitment postcode(s) [12]
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3168 - Melbourne
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Illinois
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Maryland
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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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Plovdiv
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Varna
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Bulgaria
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Vratsa
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Zagreb
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Hradec Kralove
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Praha 2
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Aalborg
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Odense
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Cairo
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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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Erlangen
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Eschweiler
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Germany
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Essen
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Esslingen
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Frankfurt am Main
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Germany
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Germany
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Frankfurt
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Frechen
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Giessen
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Greifswald
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Göttingen
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Hamm
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Heidelberg
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Karlsruhe
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Kempten
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Germany
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Kiel
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Koblenz
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Koeln
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Leer
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Lemgo
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Mainz
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Mannheim
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Muenchen
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München
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Oldenburg
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Porta Westfalica
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Germany
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Regensburg
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Germany
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Rostock
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Germany
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Rüsselsheim
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Germany
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Saarbruecken
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Germany
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Sindelfingen
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Germany
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Stuttgart
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Trier
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Tübingen
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Ulm
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Villingen-Schwenningen
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Weilheim
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Germany
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Witten
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Worms
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Hong Kong
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Hong Kong
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Italy
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Italy
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Ferrara
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Italy
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Genova
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Italy
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Messina
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Italy
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Milano
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Italy
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Modena
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Italy
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Orbassano
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Italy
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Roma
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Italy
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Terni
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Italy
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Torino
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Mexico
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Aguascalientes
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Hermosillo
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Mexico
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Monterrey
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Mexico
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Netherlands
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Penza
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Perm
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Russian Federation
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Nottingham
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Country
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Other collaborator category [1]
0
0
Other
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Name [1]
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0
German CLL Study Group
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0
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0
0
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Other collaborator category [2]
0
0
Commercial sector/industry
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Name [2]
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Genentech, Inc.
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Address [2]
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0
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0
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Ethics approval
Ethics application status
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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 (1000mg 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.
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Trial website
https://clinicaltrials.gov/study/NCT01998880
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Address
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Hoffmann-La Roche
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01998880
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