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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01332968




Registration number
NCT01332968
Ethics application status
Date submitted
8/04/2011
Date registered
11/04/2011
Date last updated
11/08/2022

Titles & IDs
Public title
A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)
Scientific title
A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders
Secondary ID [1] 0 0
2010-024132-41
Secondary ID [2] 0 0
BO21223
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Obinutuzumab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisone
Treatment: Drugs - Bendamustine
Treatment: Drugs - Rituximab

Active comparator: Rituximab+Chemotherapy - Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.

Experimental: Obinutuzumab+Chemotherapy - Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.


Treatment: Drugs: Obinutuzumab
Obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion will be administered on Day 1, 8, and 15 of Cycle 1 and then on Day 1 of each subsequent cycle during induction period and obinutuzumab 1000 mg IV infusion every 2 months during maintenance period.

Treatment: Drugs: Cyclophosphamide
Cyclophosphamide 750 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.

Treatment: Drugs: Doxorubicin
Doxorubicin 50 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.

Treatment: Drugs: Vincristine
Vincristine 1.4 mg/m\^2 (maximum 2 mg) IV will be administered on Day 1 of each cycle during induction period.

Treatment: Drugs: Prednisone
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone) will be administered orally on Days 1-5 of each cycle during induction period.

Treatment: Drugs: Bendamustine
Bendamustine 90 mg/m\^2 IV infusion will be administered on Days 1 and 2 of each cycle during induction period.

Treatment: Drugs: Rituximab
Rituximab 375 milligrams per square meter (mg/m\^2) IV infusion will be administered on Day 1 of each cycle during induction period and rituximab 375 mg/m\^2 every 2 months during maintenance period.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
Timepoint [1] 0 0
Baseline up to data cut-off (up to approximately 4 years and 7 months)
Secondary outcome [1] 0 0
Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
Timepoint [1] 0 0
Baseline up to final analysis (up to 10 years)
Secondary outcome [2] 0 0
Progression-Free Survival in the Overall Study Population, Investigator-Assessed
Timepoint [2] 0 0
Baseline up to data cut-off (up to approximately 5 years and 2 months)
Secondary outcome [3] 0 0
Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed
Timepoint [3] 0 0
Baseline up to data cut-off (up to approximately 5 years and 2 months)
Secondary outcome [4] 0 0
Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)
Timepoint [4] 0 0
Baseline up to data cut-off (up to approximately 5 years and 2 months)
Secondary outcome [5] 0 0
Overall Response (Follicular Lymphoma Population), Investigator-Assessed
Timepoint [5] 0 0
Baseline up to end of induction period (up to approximately 7 months)
Secondary outcome [6] 0 0
Overall Response (Overall Study Population), Investigator-Assessed
Timepoint [6] 0 0
Baseline up to end of induction period (up to approximately 7 months)
Secondary outcome [7] 0 0
Complete Response (Follicular Lymphoma Population), Investigator-Assessed
Timepoint [7] 0 0
Baseline up to end of induction period (up to approximately 7 months)
Secondary outcome [8] 0 0
Complete Response (Overall Study Population), Investigator-Assessed
Timepoint [8] 0 0
Baseline up to end of induction period (up to approximately 7 months)
Secondary outcome [9] 0 0
Overall Response (Follicular Lymphoma Population), IRC-Assessed
Timepoint [9] 0 0
Baseline up to end of induction period (up to approximately 7 months)
Secondary outcome [10] 0 0
Overall Response (Overall Study Population), IRC-Assessed
Timepoint [10] 0 0
Baseline up to end of induction period (up to approximately 7 months)
Secondary outcome [11] 0 0
Complete Response (Follicular Lymphoma Population), IRC-Assessed
Timepoint [11] 0 0
Baseline up to end of induction period (up to approximately 7 months)
Secondary outcome [12] 0 0
Complete Response (Overall Study Population), IRC-Assessed
Timepoint [12] 0 0
Baseline up to end of induction period (up to approximately 7 months)]
Secondary outcome [13] 0 0
Overall Survival (Follicular Lymphoma Population)
Timepoint [13] 0 0
Baseline up to 10 years
Secondary outcome [14] 0 0
Overall Survival (Overall Study Population)
Timepoint [14] 0 0
Baseline up to data cut-off (up to approximately 5 years and 2 months)
Secondary outcome [15] 0 0
Event-Free Survival (Follicular Lymphoma Population)
Timepoint [15] 0 0
Baseline up to 10 years
Secondary outcome [16] 0 0
Event-Free Survival (Overall Study Population)
Timepoint [16] 0 0
Baseline up to data cut-off (up to approximately 5 years and 2 months)
Secondary outcome [17] 0 0
Disease-Free Survival (Follicular Lymphoma Population)
Timepoint [17] 0 0
From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)
Secondary outcome [18] 0 0
Disease-Free Survival (Overall Study Population)
Timepoint [18] 0 0
From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)
Secondary outcome [19] 0 0
Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed
Timepoint [19] 0 0
From first occurrence of documented CR or PR to data cut-off (up to approximately 5 years and 2 months)
Secondary outcome [20] 0 0
Duration of Response (DOR) (Overall Study Population), Investigator-Assessed
Timepoint [20] 0 0
From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months)
Secondary outcome [21] 0 0
Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population)
Timepoint [21] 0 0
Baseline up to 10 years
Secondary outcome [22] 0 0
Time to Next Anti-Lymphoma Treatment (Overall Study Population)
Timepoint [22] 0 0
Baseline up to data cut-off (up to approximately 5 years and 2 months)
Secondary outcome [23] 0 0
Percentage of Participants With Adverse Events
Timepoint [23] 0 0
Baseline up to 10 years
Secondary outcome [24] 0 0
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population)
Timepoint [24] 0 0
Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
Secondary outcome [25] 0 0
Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population)
Timepoint [25] 0 0
Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
Secondary outcome [26] 0 0
Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population)
Timepoint [26] 0 0
Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
Secondary outcome [27] 0 0
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)
Timepoint [27] 0 0
Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
Secondary outcome [28] 0 0
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase
Timepoint [28] 0 0
Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)
Secondary outcome [29] 0 0
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase
Timepoint [29] 0 0
Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)
Secondary outcome [30] 0 0
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase
Timepoint [30] 0 0
Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 after Day 1 of last induction cycle, Follow-up: every year for up to data cut-off (up to 5 years and 2 months)

Eligibility
Key inclusion criteria
* Cluster of differentiation 20 (CD20)-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic, nodal or extranodal marginal zone lymphoma)
* Stage III or IV disease, or Stage II bulky disease (defined as tumor diameter greater than or equal to [>/=] 7 centimeters [cm])
* For participants with follicular lymphoma: requirement for treatment according to Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
* For participants with symptomatic splenic, nodal, or non-gastric extranodal marginal zone lymphoma: disease that is de novo or has relapsed following local therapy (i.e. surgery or radiotherapy) and requires therapy as assessed by the investigator
* At least one bi-dimensionally measurable lesion (greater than [>] 2 cm in its largest dimension by computed tomography [CT] scan or magnetic resonance imaging [MRI])
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Adequate hematologic function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
* Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenström's macroglobulinaemia
* Ann Arbor Stage I disease
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* Known hypersensitivity to any of the study drugs or sensitivity to murine products, or history of sensitivity to mannitol
* For participants with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma with chemotherapy, immunotherapy, or radiotherapy
* For participants with non-follicular lymphoma: prior treatment with chemotherapy or immunotherapy
* Regular treatment with corticosteroids during the 4 weeks prior to the start of Cycle 1
* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
* For participants who will be receiving cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP): left ventricular ejection fraction (LVEF) less than (<) 50% by multiple-gated acquisition (MUGA) scan or echocardiogram
* History of prior other malignancy with the exception of curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study
* Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1
* Vaccination with a live vaccine within 28 days prior to randomization
* Recent major surgery (within 4 weeks prior to start of Cycle 1), other than for diagnosis
* Abnormal laboratory values as defined by protocol for creatinine, creatinine clearance, aspartate transaminase (AST) or alanine transaminase (ALT), total bilirubin, international normalized ration (INR), partial thromboplastin time (PTT) or activated partial thromboplastin time (aPPT), unless these abnormalities are due to underlying lymphoma
* Positive test results for human immunodeficiency virus (HIV), human T-lymphotropic virus 1 (HTLV1), hepatitis C or chronic hepatitis B
* Pregnant or lactating women
* Life expectancy <12 months
* Participation in another clinical trial with drug intervention within 28 days prior to start of Cycle 1 and during study

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
6/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/07/2021
Sample size
Target
Accrual to date
Final
1401
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital; Haematology - Sydney
Recruitment hospital [2] 0 0
Westmead Hospital; Haematology - Sydney
Recruitment hospital [3] 0 0
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology - Woolloongabba
Recruitment hospital [4] 0 0
St Vincent'S Hospital; Haematology - Fitzroy
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre; Department of Haematology - Melbourne
Recruitment hospital [6] 0 0
Austin and Repatriation Medical Centre; Cancer Services - Melbourne
Recruitment hospital [7] 0 0
Monash Medical Centre; Haematology - Melbourne
Recruitment hospital [8] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2139 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Sydney
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3002 - Melbourne
Recruitment postcode(s) [6] 0 0
3084 - Melbourne
Recruitment postcode(s) [7] 0 0
3168 - Melbourne
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Montana
Country [9] 0 0
United States of America
State/province [9] 0 0
New Mexico
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Belgium
State/province [13] 0 0
Kortrijk
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
New Brunswick
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
China
State/province [19] 0 0
Beijing City
Country [20] 0 0
China
State/province [20] 0 0
Beijing
Country [21] 0 0
China
State/province [21] 0 0
Changchun
Country [22] 0 0
China
State/province [22] 0 0
Fuzhou City
Country [23] 0 0
China
State/province [23] 0 0
Guangzhou
Country [24] 0 0
China
State/province [24] 0 0
Harbin
Country [25] 0 0
China
State/province [25] 0 0
Nanjing City
Country [26] 0 0
China
State/province [26] 0 0
Nanjing
Country [27] 0 0
China
State/province [27] 0 0
Shanghai City
Country [28] 0 0
China
State/province [28] 0 0
Shanghai
Country [29] 0 0
China
State/province [29] 0 0
Wuhan
Country [30] 0 0
Czechia
State/province [30] 0 0
Brno
Country [31] 0 0
Czechia
State/province [31] 0 0
Hradec Kralove
Country [32] 0 0
Czechia
State/province [32] 0 0
Praha 2
Country [33] 0 0
Finland
State/province [33] 0 0
Helsinki
Country [34] 0 0
France
State/province [34] 0 0
Angers
Country [35] 0 0
France
State/province [35] 0 0
Brest
Country [36] 0 0
France
State/province [36] 0 0
Clermont Ferrand
Country [37] 0 0
France
State/province [37] 0 0
LeMans
Country [38] 0 0
France
State/province [38] 0 0
Marseille
Country [39] 0 0
France
State/province [39] 0 0
Montpellier
Country [40] 0 0
France
State/province [40] 0 0
Perpignan
Country [41] 0 0
Germany
State/province [41] 0 0
Berlin
Country [42] 0 0
Germany
State/province [42] 0 0
Chemnitz
Country [43] 0 0
Germany
State/province [43] 0 0
Dessau-Roßlau
Country [44] 0 0
Germany
State/province [44] 0 0
Dresden
Country [45] 0 0
Germany
State/province [45] 0 0
Erfurt
Country [46] 0 0
Germany
State/province [46] 0 0
Eschweiler
Country [47] 0 0
Germany
State/province [47] 0 0
Essen
Country [48] 0 0
Germany
State/province [48] 0 0
Frankfurt
Country [49] 0 0
Germany
State/province [49] 0 0
Freiburg
Country [50] 0 0
Germany
State/province [50] 0 0
Greifswald
Country [51] 0 0
Germany
State/province [51] 0 0
Göttingen
Country [52] 0 0
Germany
State/province [52] 0 0
Hagen
Country [53] 0 0
Germany
State/province [53] 0 0
Hannover
Country [54] 0 0
Germany
State/province [54] 0 0
Heidelberg
Country [55] 0 0
Germany
State/province [55] 0 0
Homburg/Saar
Country [56] 0 0
Germany
State/province [56] 0 0
Jena
Country [57] 0 0
Germany
State/province [57] 0 0
Kiel
Country [58] 0 0
Germany
State/province [58] 0 0
Koblenz
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Germany
State/province [59] 0 0
Köln
Country [60] 0 0
Germany
State/province [60] 0 0
Landshut
Country [61] 0 0
Germany
State/province [61] 0 0
Lebach
Country [62] 0 0
Germany
State/province [62] 0 0
Leipzig
Country [63] 0 0
Germany
State/province [63] 0 0
Ludwigshafen
Country [64] 0 0
Germany
State/province [64] 0 0
Magdeburg
Country [65] 0 0
Germany
State/province [65] 0 0
Mainz
Country [66] 0 0
Germany
State/province [66] 0 0
Mannheim
Country [67] 0 0
Germany
State/province [67] 0 0
Mutlangen
Country [68] 0 0
Germany
State/province [68] 0 0
Mönchengladbach
Country [69] 0 0
Germany
State/province [69] 0 0
München
Country [70] 0 0
Germany
State/province [70] 0 0
Neunkirchen/Saar
Country [71] 0 0
Germany
State/province [71] 0 0
Oldenburg
Country [72] 0 0
Germany
State/province [72] 0 0
Paderborn
Country [73] 0 0
Germany
State/province [73] 0 0
Recklinghausen
Country [74] 0 0
Germany
State/province [74] 0 0
Regensburg
Country [75] 0 0
Germany
State/province [75] 0 0
Saarbruecken
Country [76] 0 0
Germany
State/province [76] 0 0
Trier
Country [77] 0 0
Germany
State/province [77] 0 0
Tübingen
Country [78] 0 0
Germany
State/province [78] 0 0
Ulm
Country [79] 0 0
Germany
State/province [79] 0 0
Wiesbaden
Country [80] 0 0
Germany
State/province [80] 0 0
Würzburg
Country [81] 0 0
Hungary
State/province [81] 0 0
Budapest
Country [82] 0 0
Hungary
State/province [82] 0 0
Debrecen
Country [83] 0 0
Hungary
State/province [83] 0 0
Gyor
Country [84] 0 0
Hungary
State/province [84] 0 0
Szeged
Country [85] 0 0
Israel
State/province [85] 0 0
Haifa
Country [86] 0 0
Israel
State/province [86] 0 0
Petach Tikva
Country [87] 0 0
Israel
State/province [87] 0 0
Ramat-Gan
Country [88] 0 0
Italy
State/province [88] 0 0
Emilia-Romagna
Country [89] 0 0
Italy
State/province [89] 0 0
Lazio
Country [90] 0 0
Italy
State/province [90] 0 0
Lombardia
Country [91] 0 0
Italy
State/province [91] 0 0
Marche
Country [92] 0 0
Italy
State/province [92] 0 0
Sicilia
Country [93] 0 0
Italy
State/province [93] 0 0
Veneto
Country [94] 0 0
Japan
State/province [94] 0 0
Aichi
Country [95] 0 0
Japan
State/province [95] 0 0
Aomori
Country [96] 0 0
Japan
State/province [96] 0 0
Chiba
Country [97] 0 0
Japan
State/province [97] 0 0
Ehime
Country [98] 0 0
Japan
State/province [98] 0 0
Fukuoka
Country [99] 0 0
Japan
State/province [99] 0 0
Gunma
Country [100] 0 0
Japan
State/province [100] 0 0
Hiroshima
Country [101] 0 0
Japan
State/province [101] 0 0
Hyogo
Country [102] 0 0
Japan
State/province [102] 0 0
Kanagawa
Country [103] 0 0
Japan
State/province [103] 0 0
Kumamoto
Country [104] 0 0
Japan
State/province [104] 0 0
Kyoto
Country [105] 0 0
Japan
State/province [105] 0 0
Miyagi
Country [106] 0 0
Japan
State/province [106] 0 0
Nagano
Country [107] 0 0
Japan
State/province [107] 0 0
Niigata
Country [108] 0 0
Japan
State/province [108] 0 0
Osaka
Country [109] 0 0
Japan
State/province [109] 0 0
Tochigi
Country [110] 0 0
Japan
State/province [110] 0 0
Tokyo
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Moscow
Country [112] 0 0
Russian Federation
State/province [112] 0 0
Nizhny Novgorod
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Petrozavodsk
Country [114] 0 0
Spain
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Barcelona
Country [115] 0 0
Spain
State/province [115] 0 0
Madrid
Country [116] 0 0
Spain
State/province [116] 0 0
Vizcaya
Country [117] 0 0
Sweden
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Göteborg
Country [118] 0 0
Taiwan
State/province [118] 0 0
Taipei City
Country [119] 0 0
Taiwan
State/province [119] 0 0
Taipei
Country [120] 0 0
Taiwan
State/province [120] 0 0
Taoyuan
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Aberdeen
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United Kingdom
State/province [122] 0 0
Birmingham
Country [123] 0 0
United Kingdom
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Bournemouth
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United Kingdom
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Bristol
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Cambridge
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Canterbury
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Cardiff
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Cottingham
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Edinburgh
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Glasgow
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Great Yarmouth
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Harlow
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Leeds
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Leicester
Country [135] 0 0
United Kingdom
State/province [135] 0 0
London
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Manchester
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Norwich
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Nottingham
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Oxford
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Portsmouth
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Southampton
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Sutton
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Swansea
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United Kingdom
State/province [144] 0 0
Swindon
Country [145] 0 0
United Kingdom
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Truro

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 Low Grade Lymphoma Study Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Institute of Cancer Research, United Kingdom
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, participants achieving response (Complete response \[CR\] or partial response \[PR\]) will undergo a maintenance period continuing on the randomized antibody treatment alone every 2 months until disease progression for a total of 2 years. Anticipated time on study treatment is up to approximately 2.5 years. After maintenance or observation, participants will be followed for 5 years until progression. After progression, participants will be followed for new anti-lymphoma therapy and overall survival until the end of the study.
Trial website
https://clinicaltrials.gov/study/NCT01332968
Trial related presentations / publications
Casulo C, Herold M, Hiddemann W, Iyengar S, Marcus RE, Seymour JF, Launonen A, Knapp A, Nielsen TG, Mir F. Risk Factors for and Outcomes of Follicular Lymphoma Histological Transformation at First Progression in the GALLIUM Study. Clin Lymphoma Myeloma Leuk. 2023 Jan;23(1):40-48. doi: 10.1016/j.clml.2022.09.003. Epub 2022 Oct 4.
Hong X, Song Y, Shi Y, Zhang Q, Guo W, Wu G, Li J, Feng J, Kinkolykh A, Knapp A, Lin T. Efficacy and safety of obinutuzumab for the first-line treatment of follicular lymphoma: a subgroup analysis of Chinese patients enrolled in the phase III GALLIUM study. Chin Med J (Engl). 2021 Sep 16;135(4):433-440. doi: 10.1097/CM9.0000000000001737.
Strefford JC, Nowicka M, Hargreaves CE, Burton C, Davies A, Ganderton R, Hiddemann W, Iriyama C, Klapper W, Latham KV, Martelli M, Mir F, Parker H, Potter KN, Rose-Zerilli MJJ, Sehn LH, Trneny M, Vitolo U, Bolen CR, Klein C, Knapp A, Oestergaard MZ, Cragg MS. Single-nucleotide Fcgamma receptor polymorphisms do not impact obinutuzumab/rituximab outcome in patients with lymphoma. Blood Adv. 2021 Aug 10;5(15):2935-2944. doi: 10.1182/bloodadvances.2020003985.
Davies A, Trask P, Demeter J, Florschutz A, Hanel M, Kinoshita T, Pettengell R, Quach H, Robinson S, Sadullah S, Sancho JM, Udvardy M, Witzens-Harig M, Knapp A, Liu W. Health-related quality of life in the phase III GALLIUM study of obinutuzumab- or rituximab-based chemotherapy in patients with previously untreated advanced follicular lymphoma. Ann Hematol. 2020 Dec;99(12):2837-2846. doi: 10.1007/s00277-020-04021-6. Epub 2020 Apr 20.
Klanova M, Oestergaard MZ, Trneny M, Hiddemann W, Marcus R, Sehn LH, Vitolo U, Bazeos A, Goede V, Zeuner H, Knapp A, Sahin D, Spielewoy N, Bolen CR, Cardona A, Klein C, Venstrom JM, Nielsen T, Fingerle-Rowson G. Prognostic Impact of Natural Killer Cell Count in Follicular Lymphoma and Diffuse Large B-cell Lymphoma Patients Treated with Immunochemotherapy. Clin Cancer Res. 2019 Aug 1;25(15):4634-4643. doi: 10.1158/1078-0432.CCR-18-3270. Epub 2019 May 3.
Kusumoto S, Arcaini L, Hong X, Jin J, Kim WS, Kwong YL, Peters MG, Tanaka Y, Zelenetz AD, Kuriki H, Fingerle-Rowson G, Nielsen T, Ueda E, Piper-Lepoutre H, Sellam G, Tobinai K. Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy. Blood. 2019 Jan 10;133(2):137-146. doi: 10.1182/blood-2018-04-848044. Epub 2018 Oct 19.
Trotman J, Barrington SF, Belada D, Meignan M, MacEwan R, Owen C, Ptacnik V, Rosta A, Fingerle-Rowson GR, Zhu J, Nielsen T, Sahin D, Hiddemann W, Marcus RE, Davies A; PET investigators from the GALLIUM study. Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM): secondary analysis of a randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1530-1542. doi: 10.1016/S1470-2045(18)30618-1. Epub 2018 Oct 8. Erratum In: Lancet Oncol. 2019 Jun;20(6):e293. doi: 10.1016/S1470-2045(19)30280-3.
Hiddemann W, Barbui AM, Canales MA, Cannell PK, Collins GP, Durig J, Forstpointner R, Herold M, Hertzberg M, Klanova M, Radford J, Seymour JF, Tobinai K, Trotman J, Burciu A, Fingerle-Rowson G, Wolbers M, Nielsen T, Marcus RE. Immunochemotherapy With Obinutuzumab or Rituximab for Previously Untreated Follicular Lymphoma in the GALLIUM Study: Influence of Chemotherapy on Efficacy and Safety. J Clin Oncol. 2018 Aug 10;36(23):2395-2404. doi: 10.1200/JCO.2017.76.8960. Epub 2018 Jun 1.
Marcus R, Davies A, Ando K, Klapper W, Opat S, Owen C, Phillips E, Sangha R, Schlag R, Seymour JF, Townsend W, Trneny M, Wenger M, Fingerle-Rowson G, Rufibach K, Moore T, Herold M, Hiddemann W. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med. 2017 Oct 5;377(14):1331-1344. doi: 10.1056/NEJMoa1614598.
Public notes

Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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Phone 0 0
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Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01332968