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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02053610




Registration number
NCT02053610
Ethics application status
Date submitted
25/11/2013
Date registered
3/02/2014
Date last updated
14/09/2018

Titles & IDs
Public title
CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)
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; CLL1
Secondary ID [2] 0 0
BO21004 (Stage 2)
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)
Timepoint [1] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Primary outcome [2] 0 0
Percentage of Participants With Progression Free Survival Events
Timepoint [2] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Secondary outcome [1] 0 0
Progression Free Survival Based on Independent Review Committee (IRC) Data
Timepoint [1] 0 0
Randomization to clinical cutoff of 09 May 2013 (median observation 18.7 months)
Secondary outcome [2] 0 0
Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data
Timepoint [2] 0 0
Randomization to clinical cutoff of 09 May 2013 (median observation 18.7 months)
Secondary outcome [3] 0 0
Percentage of Participants With End of Treatment Response (EOTR)
Timepoint [3] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Secondary outcome [4] 0 0
Percentage of Participants With Best Overall Response
Timepoint [4] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Secondary outcome [5] 0 0
Event Free Survival
Timepoint [5] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Secondary outcome [6] 0 0
Overall Survival
Timepoint [6] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Secondary outcome [7] 0 0
Duration of Response
Timepoint [7] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Secondary outcome [8] 0 0
Percentage of Participants With Molecular Remission at the End of Treatment
Timepoint [8] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Secondary outcome [9] 0 0
Time to Re-Treatment/New Anti-leukemic Therapy
Timepoint [9] 0 0
Randomization to clinical cutoff (median observation 59.4 months)
Secondary outcome [10] 0 0
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
Timepoint [10] 0 0
Baseline and Cycle 4 Day 1 (Cy4D1)
Secondary outcome [11] 0 0
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire
Timepoint [11] 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
Sex
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 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.

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
31/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/08/2017
Sample size
Target
Accrual to date
Final
787
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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Illinois
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Maryland
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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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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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Varna
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Bulgaria
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Vratsa
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Alberta
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Manitoba
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Ontario
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Zagreb
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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
State/province [30] 0 0
Odense
Country [31] 0 0
Denmark
State/province [31] 0 0
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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Creteil
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Le Mans
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Lille
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Lyon
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Marseille
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Montpellier
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Nantes
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Pessac
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Pierre Benite
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France
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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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Amberg
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Ansbach
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Bamberg
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Berlin
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Germany
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Bonn
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Bremen
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Delitzsch
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Detmold
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Dresden
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Duisburg
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Erlangen
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Eschweiler
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Essen
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Esslingen
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Frankfurt am Main
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Frankfurt an der Oder
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Frankfurt
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Frechen
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Freiburg
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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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Kiel
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Koblenz
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Koeln
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Kronach
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Köln
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Landshut
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Lebach
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Leer
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Lemgo
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Lörrach
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Lüdenscheid
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Magedburg
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Mainz
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Mannheim
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Muenchen
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Mutlangen
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München
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Neunkirchen/Saar
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Nürnberg
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Germany
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Oldenburg
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Porta Westfalica
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Ravensburg
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Recklinghausen
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Regensburg
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Rostock
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Rüsselsheim
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Sindelfingen
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Stuttgart
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Trier
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Tübingen
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Germany
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Ulm
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Germany
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Villingen-Schwenningen
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Germany
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Weilheim
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Germany
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Wendlingen
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Germany
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Witten
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Germany
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Worms
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Germany
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Wuerzburg
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Germany
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Würzburg
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Hong Kong
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Hong Kong
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Italy
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Calabria
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Piemonte
Country [134] 0 0
Italy
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Sardegna
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Italy
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Sicilia
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Italy
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Umbria
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Mexico
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Aguascalientes
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Mexico
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Culiacan
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Mexico
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Hermosillo
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Mexico
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Monterrey
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Mexico
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San Luis Potosi
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Netherlands
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Delftzijl
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Enschede
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Leeuwarden
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Netherlands
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Nieuwegein
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New Zealand
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Auckland
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New Zealand
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Christchurch
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Kazan
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Russian Federation
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Nizhny Novgorod
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Penza
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Perm
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Rostov-na-donu
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UFA
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Cadiz
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Guipuzcoa
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LA Coruña
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Spain
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Navarra
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Spain
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Tenerife
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Valencia
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Spain
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Jaen
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Spain
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Las Palmas
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Murcia
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Spain
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Salamanca
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Spain
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Sevilla
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Spain
State/province [174] 0 0
Toledo
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Spain
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Zaragoza
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Switzerland
State/province [176] 0 0
Aarau
Country [177] 0 0
Switzerland
State/province [177] 0 0
Basel
Country [178] 0 0
Switzerland
State/province [178] 0 0
Bern
Country [179] 0 0
Switzerland
State/province [179] 0 0
Chur
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Switzerland
State/province [180] 0 0
Luzern
Country [181] 0 0
Switzerland
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St. Gallen
Country [182] 0 0
Switzerland
State/province [182] 0 0
Zürich
Country [183] 0 0
Thailand
State/province [183] 0 0
Bangkok
Country [184] 0 0
Thailand
State/province [184] 0 0
Khon Kaen
Country [185] 0 0
United Kingdom
State/province [185] 0 0
Bournemouth
Country [186] 0 0
United Kingdom
State/province [186] 0 0
Cambridge
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Canterbury
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Cardiff
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Cottingham
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Edinburgh
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Glasgow
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Leicester
Country [193] 0 0
United Kingdom
State/province [193] 0 0
London
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Nottingham
Country [195] 0 0
United Kingdom
State/province [195] 0 0
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/ct2/show/NCT02053610
Trial related presentations / publications
Public notes

Contacts
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Hoffmann-La Roche
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