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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02242942




Registration number
NCT02242942
Ethics application status
Date submitted
16/09/2014
Date registered
17/09/2014
Date last updated
22/09/2020

Titles & IDs
Public title
A Study to Compare the Efficacy and Safety of Obinutuzumab + Venetoclax (GDC-0199) Versus Obinutuzumab + Chlorambucil in Participants With Chronic Lymphocytic Leukemia
Scientific title
A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax (GDC-0199/ABT-199) Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions
Secondary ID [1] 0 0
2014-001810-24
Secondary ID [2] 0 0
BO25323
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 - Chlorambucil
Treatment: Drugs - Venetoclax
Treatment: Drugs - Obinutuzumab

Experimental: Safety Run-in Obinutuzumab + Venetoclax - Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.

Experimental: Obinutuzumab + Chlorambucil - Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.

Experimental: Obinutuzumab + Venetoclax - Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.


Treatment: Drugs: Chlorambucil
Chlorambucil 0.5 milligrams per kilogram (mg/kg) orally at Day 1 and Day 15 at of each 28 day cycle for 12 cycles.

Treatment: Drugs: Venetoclax
Venetoclax, oral tablet: 20 mg daily during Cycle 1, Day 22-28; 50 mg daily during Cycle 2, Day 1-7; 100 mg daily during Cycle 2, Day 8-14; 200 mg daily during Cycle 2, Day 15-21; 400 mg daily during Cycle 2, Day 22-28 and on Day 1-28 for all subsequent cycles until the end of Cycle 12.

Treatment: Drugs: Obinutuzumab
Obinutuzumab, IV infusion: 100 mg or 1000 mg, depending on splitting rules, at Cycle 1, Day 1 (if 100 mg was received on Day 1, 900 mg will be administered on Cycle 1, Day 2); 1000 mg at Cycle 1, Day 8 and Day 15; 1000 mg at Day 1 for all subsequent cycles until the end of Cycle 6

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

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria - PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of PD or death from any cause. Disease progression was characterized by at least one of the following: 1) >/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (> 15 mm in longest diameter) or any new extra-nodal lesion; 3) >/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) >/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.
Timepoint [1] 0 0
Baseline until disease progression or death up to approximately 3.75 years
Secondary outcome [1] 0 0
Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria - PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause. Disease progression was characterized by at least one of the following: 1) >/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (> 15 mm in longest diameter) or any new extra-nodal lesion; 3) >/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) >/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.
Timepoint [1] 0 0
Baseline until disease progression or death up to approximately 3.75 years
Secondary outcome [2] 0 0
Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria - OR was defined as complete response (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and computed tomography (CT) scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: two of the following features for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L.
Timepoint [2] 0 0
At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
Secondary outcome [3] 0 0
Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria - CRR was defined as the rate of a clinical response of CR or CRi according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri).
Timepoint [3] 0 0
At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
Secondary outcome [4] 0 0
Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood as Measured by Allele-Specific Oligonucleotide Polymerase Chain Reaction (ASO-PCR) at Completion of Treatment - MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in peripheral blood.
Timepoint [4] 0 0
At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
Secondary outcome [5] 0 0
Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment - MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in bone marrow.
Timepoint [5] 0 0
At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)
Secondary outcome [6] 0 0
Overall Survival (OS) - OS was defined as the time between the date of randomization and the date of death due to any cause.
Timepoint [6] 0 0
Baseline until death, up to approximately 5.75 years
Secondary outcome [7] 0 0
Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment - MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in peripheral blood.
Timepoint [7] 0 0
Day 1 Cycle 9 or 3 months after last IV infusion, approximately 9 months
Secondary outcome [8] 0 0
Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Combination Treatment Assessment - MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in bone marrow.
Timepoint [8] 0 0
Day 1 Cycle 9 or 3 months after last IV infusion at approximately 9 months
Secondary outcome [9] 0 0
Percentage of Participants With OR at Completion of Combination Treatment Response Assessment - OR was defined as CR, CRi or PR according to IWCLL 2008 criteria. CR required all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L. PR: two of the following features for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L.
Timepoint [9] 0 0
Day 1 Cycle 7 or 28 days after last IV infusion, approximately 6 months
Secondary outcome [10] 0 0
Duration of Objective Response (DOR) - PD was defined as lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia.
Timepoint [10] 0 0
Time from the first occurrence of a documented objective response to the time of PD as determined by the investigator or death from any cause, up to approximately 5.75 years
Secondary outcome [11] 0 0
Percentage of Participants By Best Response Achieved (CR, CRi, PR, Stable Disease (SD), or PD) - CR: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: any two for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L. PD: lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia. SD: a non-response and used to characterize participants who did not achieve a CR or a PR, and who have not exhibited PD.
Timepoint [11] 0 0
Baseline up to the completion of treatment assessment 3 months after treatment completion (up to approximately 15 months)
Secondary outcome [12] 0 0
Event-Free Survival
Timepoint [12] 0 0
Time between date of randomization and the date of disease progression/relapse on the basis of investigator-assessment, death, or start of a new anti-leukemic therapy, up to 5.75 years
Secondary outcome [13] 0 0
Time to Next Anti-Leukemic Treatment
Timepoint [13] 0 0
Time between the date of randomization and the date of first intake of new anti-leukemic therapy, up to 5.75 years
Secondary outcome [14] 0 0
Number of Participants With Adverse Events (AEs) - An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs.
Timepoint [14] 0 0
Up to approximately 5.75 years
Secondary outcome [15] 0 0
Percentage of Participants With CD19 + /CD5+ B Cells or CD14+ Monocytes
Timepoint [15] 0 0
Baseline up to approximately 5.75 years
Secondary outcome [16] 0 0
Percentage of Participants With Human-Anti-Human Antibodies
Timepoint [16] 0 0
Baseline up to approximately 5.75 years
Secondary outcome [17] 0 0
Percentage of Participants Recorded as Premature Study Withdrawals
Timepoint [17] 0 0
Up to approximately 5.75 years
Secondary outcome [18] 0 0
Plasma Concentrations of Venetoclax
Timepoint [18] 0 0
Pre-venetoclax dose (0 hour) and 4 hours post- venetoclax dose on Day 1 Cycle 4
Secondary outcome [19] 0 0
Serum Concentrations of Obinutuzumab
Timepoint [19] 0 0
Pre-obinutuzumab infusion (0 hour) and end of obinutuzumab infusion on Day 1 Cycle 4
Secondary outcome [20] 0 0
Change From Baseline in M.D. Anderson Symptom Inventory-CLL (MDASI-CLL) Score - The MDASI-CLL is a questionnaire of 25 items related to CLL specific symptoms that a participant may have experienced in the past 24 hours. Participants were asked to rate the severity of 13 symptoms called mean core symptom severity (i.e., pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, and numbness or tingling), 6 disease-specific symptoms called mean module symptom severity (night sweats, fevers and chills, lymph node swelling, diarrhea, easy bruising or bleeding, and constipation) and 6 mean interference on life questions (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) on a scale from 0 to 10 with 0 indicating that the symptom is "not present" or "did not interfere" with the participant's activities and 10 indicating "as bad as you can imagine" or "interfered completely". Scores were averaged (range 0 to 10) for each of three parts.
Timepoint [20] 0 0
Baseline up to approximately 5.75 years
Secondary outcome [21] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQC30) - The EORTC QLQ-C30 is a validated and reliable self-report measure consisting of 30 questions incorporated into five functional scales (physical, role, cognitive, emotional, and social scales), three symptom scales (fatigue, pain, nausea, and vomiting scales), and a global health status/global quality-of-life scale. The remaining single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) assess the additional symptoms experienced by patients with cancer and the perceived financial burden of treatment. The 28 function and symptom items were scored on a 4-point scale that ranged from "not at all" to "very much," and the 2 global health status/global quality-of-life items were scored on a 7-point scale that ranged from "very poor" to "excellent." Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e., higher functioning, higher symptom severity).
Timepoint [21] 0 0
Baseline up to approximately 5.75 years
Secondary outcome [22] 0 0
Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D-3L) - The EQ-5D-3L questionnaire is a generic, preference based health utility measure that assesses 5 health states (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and is used to build a composite of the patient's health status. The EQ-5D-3L was employed in this study to calculate health utilities for economic modeling, which ranged 0-1. The EQ-5D-3L also contained a visual analog scale (VAS) to assess the participant's overall health, which ranged from 0-100 with a higher score indicating a worse health status.
Timepoint [22] 0 0
Baseline up to approximately 5.75 years

Eligibility
Key inclusion criteria
- Documented previously untreated CLL according to the International Workshop on Chronic
Lymphocytic Leukemia (IWCLL) criteria

- CLL requiring treatment according to IWCLL criteria

- Total Cumulative Illness Rating Scale (CIRS score) greater than (>) 6

- Adequate marrow function independent of growth factor or transfusion support within 2
weeks of screening as per protocol, unless cytopenia is due to marrow involvement of
CLL

- Adequate liver function

- Life expectancy > 6 months

- Agreement to use highly effective contraceptive methods per protocol
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation
or pro-lymphocytic leukemia)

- Known central nervous system involvement

- Participants with a history of confirmed progressive multifocal leukoencephalopathy
(PML)

- An individual organ/ system impairment score of 4 as assessed by the CIRS definition
limiting the ability to receive the treatment regimen of this trial with the exception
of eyes, ears, nose, throat organ system

- Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia

- Inadequate renal function

- History of prior malignancy, except for conditions as listed in the protocol if
participants have recovered from the acute side effects incurred as a result of
previous therapy

- Use of investigational agents or concurrent anti-cancer treatment within the last 4
weeks of registration

- Participants with active bacterial, viral, or fungal infection requiring systemic
treatment within the last two months prior to registration

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies or known sensitivity or allergy to murine products

- Hypersensitivity to chlorambucil, obinutuzumab, or venetoclax or to any of the
excipients

- Pregnant women and nursing mothers

- Positive test results for chronic hepatitis B virus (HBV) infection (defined as
positive hepatitis B surface antigen [HBsAg] serology) or positive test result for
hepatitis C (hepatitis C virus [HCV] antibody serology testing)

- Participants with known infection with human immunodeficiency virus (HIV) or human
T-cell leukemia virus-1 (HTLV-1)

- Requires the use of warfarin, marcumar, or phenprocoumon

- Received agents known to be strong and moderate Cytochrome P450 3A inhibitors or
inducers within 7 days prior to the first dose of study drug

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
Active, not recruiting
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
The Northern Hospital - Epping
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Tweed Hospital - Tweed Heads
Recruitment hospital [4] 0 0
The Townsville Hospital - Douglas
Recruitment hospital [5] 0 0
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology - Woolloongabba
Recruitment hospital [6] 0 0
Royal Adelaide Hospital; Haematology Clinical Trials - Adelaide
Recruitment hospital [7] 0 0
Ashford Cancer Centre Research; Internal Medicine/Medical Oncology - Ashford
Recruitment hospital [8] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [9] 0 0
Monash Medical Centre; Haematology - Melbourne
Recruitment postcode(s) [1] 0 0
3076 - Epping
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [4] 0 0
4814 - Douglas
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5035 - Ashford
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Austria
State/province [9] 0 0
Innsbruck
Country [10] 0 0
Austria
State/province [10] 0 0
Wien
Country [11] 0 0
Brazil
State/province [11] 0 0
RS
Country [12] 0 0
Brazil
State/province [12] 0 0
SP
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Pleven
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Plovdiv
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Sofia
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Vratsa
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
Nova Scotia
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Croatia
State/province [20] 0 0
Zagreb
Country [21] 0 0
Denmark
State/province [21] 0 0
Herlev
Country [22] 0 0
Denmark
State/province [22] 0 0
København Ø
Country [23] 0 0
Denmark
State/province [23] 0 0
Roskilde
Country [24] 0 0
Denmark
State/province [24] 0 0
Vejle
Country [25] 0 0
Estonia
State/province [25] 0 0
Tallinn
Country [26] 0 0
Estonia
State/province [26] 0 0
Tartu
Country [27] 0 0
France
State/province [27] 0 0
Besançon Cedex
Country [28] 0 0
France
State/province [28] 0 0
Caen
Country [29] 0 0
France
State/province [29] 0 0
Clermont Ferrand
Country [30] 0 0
France
State/province [30] 0 0
Creteil
Country [31] 0 0
France
State/province [31] 0 0
Dijon
Country [32] 0 0
France
State/province [32] 0 0
Grenoble
Country [33] 0 0
France
State/province [33] 0 0
Le Mans
Country [34] 0 0
France
State/province [34] 0 0
Lyon
Country [35] 0 0
France
State/province [35] 0 0
Montpellier
Country [36] 0 0
France
State/province [36] 0 0
Nantes
Country [37] 0 0
France
State/province [37] 0 0
Paris
Country [38] 0 0
France
State/province [38] 0 0
Rennes
Country [39] 0 0
France
State/province [39] 0 0
Rouen
Country [40] 0 0
France
State/province [40] 0 0
Toulon
Country [41] 0 0
France
State/province [41] 0 0
Villejuif
Country [42] 0 0
Germany
State/province [42] 0 0
Aachen
Country [43] 0 0
Germany
State/province [43] 0 0
Amberg
Country [44] 0 0
Germany
State/province [44] 0 0
Berlin
Country [45] 0 0
Germany
State/province [45] 0 0
Dresden
Country [46] 0 0
Germany
State/province [46] 0 0
Essen
Country [47] 0 0
Germany
State/province [47] 0 0
Esslingen
Country [48] 0 0
Germany
State/province [48] 0 0
Frankfurt/Oder
Country [49] 0 0
Germany
State/province [49] 0 0
Freiburg
Country [50] 0 0
Germany
State/province [50] 0 0
Göttingen
Country [51] 0 0
Germany
State/province [51] 0 0
Heidelberg
Country [52] 0 0
Germany
State/province [52] 0 0
Herne
Country [53] 0 0
Germany
State/province [53] 0 0
Koblenz
Country [54] 0 0
Germany
State/province [54] 0 0
Köln
Country [55] 0 0
Germany
State/province [55] 0 0
Landshut
Country [56] 0 0
Germany
State/province [56] 0 0
Munchen
Country [57] 0 0
Germany
State/province [57] 0 0
Mutlangen
Country [58] 0 0
Germany
State/province [58] 0 0
Mönchengladbach
Country [59] 0 0
Germany
State/province [59] 0 0
München
Country [60] 0 0
Germany
State/province [60] 0 0
Neunkirchen/Saar
Country [61] 0 0
Germany
State/province [61] 0 0
Paderborn
Country [62] 0 0
Germany
State/province [62] 0 0
Regensburg
Country [63] 0 0
Germany
State/province [63] 0 0
Stuttgart
Country [64] 0 0
Germany
State/province [64] 0 0
Tuebingen
Country [65] 0 0
Germany
State/province [65] 0 0
Ulm
Country [66] 0 0
Germany
State/province [66] 0 0
Weiden
Country [67] 0 0
Italy
State/province [67] 0 0
Emilia-Romagna
Country [68] 0 0
Italy
State/province [68] 0 0
Lazio
Country [69] 0 0
Italy
State/province [69] 0 0
Lombardia
Country [70] 0 0
Italy
State/province [70] 0 0
Umbria
Country [71] 0 0
Italy
State/province [71] 0 0
Veneto
Country [72] 0 0
Mexico
State/province [72] 0 0
Culiacan
Country [73] 0 0
New Zealand
State/province [73] 0 0
Christchurch
Country [74] 0 0
New Zealand
State/province [74] 0 0
Dunedin
Country [75] 0 0
New Zealand
State/province [75] 0 0
Palmerston North
Country [76] 0 0
New Zealand
State/province [76] 0 0
Wellington
Country [77] 0 0
Poland
State/province [77] 0 0
Bialystok
Country [78] 0 0
Poland
State/province [78] 0 0
Chorzów
Country [79] 0 0
Poland
State/province [79] 0 0
Lodz
Country [80] 0 0
Poland
State/province [80] 0 0
Slupsk
Country [81] 0 0
Poland
State/province [81] 0 0
Wroclaw
Country [82] 0 0
Romania
State/province [82] 0 0
Bucharest
Country [83] 0 0
Romania
State/province [83] 0 0
Iasi
Country [84] 0 0
Romania
State/province [84] 0 0
Targu-mures
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Kazan
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Moscow
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Nizhny Novgorod
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Penza
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Perm
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Rostov-na-donu
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Ufa
Country [92] 0 0
Spain
State/province [92] 0 0
Navarra
Country [93] 0 0
Spain
State/province [93] 0 0
Tenerife
Country [94] 0 0
Spain
State/province [94] 0 0
Barcelona
Country [95] 0 0
Spain
State/province [95] 0 0
Madrid
Country [96] 0 0
Spain
State/province [96] 0 0
Salamanca
Country [97] 0 0
Spain
State/province [97] 0 0
Sevilla
Country [98] 0 0
Spain
State/province [98] 0 0
Toledo
Country [99] 0 0
Spain
State/province [99] 0 0
Valencia
Country [100] 0 0
Switzerland
State/province [100] 0 0
Bern
Country [101] 0 0
Switzerland
State/province [101] 0 0
Luzern
Country [102] 0 0
Switzerland
State/province [102] 0 0
Zürich
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Birmingham
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Boston,Lincolnshire
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Edinburgh
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Lincoln
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Southhampton

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

Ethics approval
Ethics application status

Summary
Brief summary
This open-label, multicenter, randomized Phase III study is designed to compare the efficacy
and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab +
chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical
conditions. The anticipated time on study treatment will be approximately one year and the
follow-up period will be up to 5 years.
Trial website
https://clinicaltrials.gov/show/NCT02242942
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

Summary results
Other publications