A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With MabThera/Rituxan (Rituximab) Plus Chemotherapy Followed by GA101 or MabThera/Rituxan Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
German Low Grade Lymphoma Study Group
Institute of Cancer Research, United Kingdom
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01332968
First received: April 8, 2011
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

This open-label, randomized study will assess the efficacy and safety of obinutu zumab (RO5072759) in combination with chemotherapy compared to MabThera/Rituxan (rituximab) with chemotherapy followed by obinutuzumab or MabThera/Rituxan maint enance in patients with untreated advanced indolent non-Hodgkin's lymphoma. Afte r the end of the induction period, patients achieving response (CR or PR) will g

o on to a maintenance period thereby continuing on their randomized antibody tre atment alone every 2 months until disease progression for a total of 2 years. An ticipated time on study treatment is up to approximately 2.5 years. After mainte nance or observation patients will be followed for 5 years until progression. Af ter progression, patients will be followed for new anti-lymphoma therapy and ove rall survival until the end of the study.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: RO5072759
Drug: rituximab [MabThera/Rituxan]
Drug: chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre, Phase III, Open Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) + Chemotherapy Compared to Rituximab + Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival in patients with follicular lymphoma, investigator-assessed according to the Revised Response Criteria for Malignant Lymphoma [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival in the overall study population, investigator-assessed [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
  • Progression-free survival, Independent Review Committee - assessed [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
  • Response (overall response and complete response), investigator-assessed [ Time Frame: 168 days ] [ Designated as safety issue: No ]
  • Response (overall response and complete response), Independent Review Committee - assessed [ Time Frame: 168 days ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to approximately 10.7 years ] [ Designated as safety issue: No ]
  • Event-free survival [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
  • Time to next anti-lymphoma treatment [ Time Frame: up to approximately 10.7 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 10.7 years ] [ Designated as safety issue: No ]
  • Patient-reported outcomes (Functional Assessment of Cancer Therapy for Lymphoma scale, EuroQol EQ-5D questionnaire) [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
  • Medical resource utilization (hospitalizations, subsequent drug therapies, medical and surgical procedures) [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]

Enrollment: 1401
Study Start Date: July 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: rituximab [MabThera/Rituxan]
375 mg/m2 iv on Day 1 of Cycles 1-8 (21-day cycles) or Cycles 1-6 (28-day cycles); followed by 375 mg/m2 iv every 2 months in responders until disease progression, for up to 2 years
Drug: chemotherapy
CHOP (6 cycles of 21 days), CVP (8 cycles of 21 days), Bendamustine (6 cycles of 28 days). Patients with follicular lymphoma are receiving either CHOP, CVP or Bendamustine as background chemotherapy as selected by each participating site at study start. Background chemotherapy for patients with non-follicular lymphoma will be chosen by the site individually for each patient.
Experimental: B Drug: RO5072759
1000 mg iv on Days 1, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2-8 (21-day cycles) or Cycles 2-6 (28-day cycles); followed by 1000 mg iv every 2 months in responders until disease progression, for up to 2 years
Drug: chemotherapy
CHOP (6 cycles of 21 days), CVP (8 cycles of 21 days), Bendamustine (6 cycles of 28 days). Patients with follicular lymphoma are receiving either CHOP, CVP or Bendamustine as background chemotherapy as selected by each participating site at study start. Background chemotherapy for patients with non-follicular lymphoma will be chosen by the site individually for each patient.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • 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 tumour diameter >/= 7 cm), requiring treatment
  • For patients with follicular lymphoma: requirement for treatment according to GELF criteria
  • For patients with symptomatic 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 (>2 cm in its largest dimension by CT scan or MRI)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Adequate hematologic function

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 patients with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma with chemotherapy, immunotherapy, or radiotherapy
  • For patients 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 patients who will be receiving CHOP: LVEF <50% by MUGA scan or echocardiogram
  • History of prior malignancy with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
  • 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, AST or ALT, total bilirubin, INR, PTT or aPPT, unless these abnormalities are due to underlying lymphoma
  • Positive as per protocol definition for HIV, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332968

  Hide Study Locations
Locations
United States, Arkansas
Rogers, Arkansas, United States, 72758
United States, California
Irvine, California, United States, 92697
United States, Idaho
Post Falls, Idaho, United States, 83854
United States, Illinois
Galesburg, Illinois, United States, 61401
United States, Iowa
Sioux City, Iowa, United States, 51101
United States, Kansas
Westwood, Kansas, United States, 66205
Wichita, Kansas, United States, 67214-3728
United States, Missouri
Springfield, Missouri, United States, 65807
United States, Montana
Missoula, Montana, United States, 59802
United States, New Mexico
Farmington, New Mexico, United States, 87401
United States, Oregon
Portland, Oregon, United States, 97225
United States, Washington
Tacoma, Washington, United States, 98405
Australia, New South Wales
Sydney, New South Wales, Australia, 2145
Sydney, New South Wales, Australia, 2139
Australia, Queensland
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
East Melbourne, Victoria, Australia, 3002
Fitzroy, Victoria, Australia, 3065
Melbourne, Victoria, Australia, 3084
Melbourne, Victoria, Australia, 3168
Australia, Western Australia
Perth, Western Australia, Australia, 6000
Belgium
Gent, Belgium, 9000
Kortrijk, Belgium, 8500
Leuven, Belgium, 3000
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Edmonton, Alberta, Canada, T6G 1Z2
Canada, New Brunswick
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M9N 1N8
Toronto, Ontario, Canada, M2K 1E1
Toronto, Ontario, Canada, M4C 3E7
Canada, Quebec
Greenfield Park, Quebec, Canada, J4V 2H1
China
Beijing, China, 100142
Beijing, China, 100853
Beijing, China, 100034
Beijing, China, 100021
Changchun, China, 130021
Fuzhou, China, 350001
Fuzhou, China, 350014
Guangzhou, China, 510060
Harbin, China, 150081
Jiangsu, China, 210009
Nanjing, China, 210008
Shanghai, China, 200032
Shanghai, China, 200025
Suzhou, China, 215006
Wuhan, China, 430023
Wuhan, China, 430022
Czech Republic
Brno, Czech Republic, 625 00
Hradec Kralove, Czech Republic, 500 05
Praha 2, Czech Republic, 128 08
Finland
Helsinki, Finland, 00029
Tampere, Finland, 33520
France
Angers, France, 49933
Brest, France, 29609
Clermont Ferrand, France, 63003
LeMans, France, 72000
Marseille, France, 13005
Montpellier, France, 34295
Perpignan, France, 66046
Germany
Amberg, Germany, 92224
Berlin, Germany, 14195
Bremen, Germany, 28239
Chemnitz, Germany, 09113
Dessau-Roßlau, Germany, 06847
Dresden, Germany, 01307
Erfurt, Germany, 99089
Eschweiler, Germany, 52249
Essen, Germany, 45122
Frankfurt, Germany, 60596
Freiburg, Germany, 79106
Greifswald, Germany, 17475
Göttingen, Germany, 37075
Hagen, Germany, 58095
Hannover, Germany, 30171
Heidelberg, Germany, 69120
Heidelberg, Germany, 69115
Hof, Germany, 95028
Homburg/Saar, Germany, 66241
Idar-Oberstein, Germany, 55743
Jena, Germany, 07747
Kiel, Germany, 24116
Koblenz, Germany, 56068
Köln, Germany, 50924
Landshut, Germany, 84028
Lebach, Germany, 66822
Leipzig, Germany, 04129
Ludwigshafen, Germany, 67063
Magdeburg, Germany, 39130
Magdeburg, Germany, 39120
Magedburg, Germany, 39104
Mainz, Germany, 55131
Mannheim, Germany, 68161
Mannheim, Germany, 68167
Muenchen, Germany, 81377
Muenster, Germany, 48149
Mutlangen, Germany, 73557
Mönchengladbach, Germany, 41063
München, Germany, 81675
Münster, Germany, 48149
Neunkirchen/Saar, Germany, 66538
Oldenburg, Germany, 26121
Paderborn, Germany, 33098
Recklinghausen, Germany, 45659
Regensburg, Germany, 93049
Saarbruecken, Germany, 66113
Stade, Germany, 21680
Stuttgart, Germany, 70176
Trier, Germany, 54292
Tübingen, Germany, 72076
Ulm, Germany, 89081
Wiesbaden, Germany, 65199
Würzburg, Germany, 97080
Hungary
Budapest, Hungary, 1083
Budapest, Hungary, 1122
Debrecen, Hungary, 4032
Gyor, Hungary, 9024
Kaposvar, Hungary, 7400
Szeged, Hungary, 6720
Israel
Haifa, Israel, 31096
Jerusalem, Israel, 9112001
Petach Tikva, Israel, 49100
Ramat Gan, Israel, 52662
Italy
Modena, Emilia-Romagna, Italy, 41100
Roma, Lazio, Italy, 00152
Bergamo, Lombardia, Italy, 24127
Milano, Lombardia, Italy, 20122
Milano, Lombardia, Italy, 20162
Rozzano, Lombardia, Italy, 20089
Torrette Di Ancona, Marche, Italy, 60020
Palermo, Sicilia, Italy, 90146
Padova, Veneto, Italy, 35128
Japan
Aichi, Japan, 467-8602
Aichi, Japan, 464-8681
Aichi, Japan, 466-8650
Aomori, Japan, 030-8553
Chiba, Japan, 260-8717
Chiba, Japan, 277-8577
Ehime, Japan, 791-0280
Fukuoka, Japan, 811-1395
Gunma, Japan, 371-8511
Hiroshima, Japan, 734-8551
Hyogo, Japan, 650-0047
Hyogo, Japan, 673-8558
Kanagawa, Japan, 259-1193
Kumamoto, Japan, 860-8556
Kyoto, Japan, 602-8566
Miyagi, Japan, 980-8574
Nagano, Japan, 390-8621
Niigata, Japan, 951-8566
Osaka, Japan, 570-8540
Tochigi, Japan, 329-0498
Tokyo, Japan, 135-8550
Tokyo, Japan, 105-8470
Tokyo, Japan, 104-0045
Tokyo, Japan, 201-8601
Russian Federation
Moscow, Russian Federation, 115478
Nizhny Novgorod, Russian Federation, 603126
Petrozavodsk, Russian Federation, 185019
Spain
Badalona, Barcelona, Spain, 08915
Sabadell, Barcelona, Spain, 08208
Alcorcon, Madrid, Spain, 28922
Bilbao, Vizcaya, Spain, 48013
Madrid, Spain, 28041
Madrid, Spain, 28046
Sweden
Göteborg, Sweden, S-413 45
Stockholm, Sweden, 118 83
Taiwan
Taipei, Taiwan, 100
Taipei, Taiwan, 112
Taoyuan, Taiwan, 333
United Kingdom
Aberdeen, United Kingdom, AB25 2ZN
Birmingham, United Kingdom, B15 2TH
Bournemouth, United Kingdom, BH7 7DW
Bristol, United Kingdom, BS2 8ED
Cambridge, United Kingdom, CB2 0QQ
Canterbury, United Kingdom, CT1 3NG
Cardiff, United Kingdom, CF14 2TL
Cottingham, United Kingdom, HU16 5JG
Edinburgh, United Kingdom, EH4 2XU
Glasgow, United Kingdom, G12 0YN
Great Yarmouth, United Kingdom, NR31 6LA
Harlow, United Kingdom, CM20 1QX
Leeds, United Kingdom, LS9 7TF
Leicester, United Kingdom, LE1 5WW
London, United Kingdom, SE5 9RS
London, United Kingdom, EC1M 6BQ
London, United Kingdom, NW3 2QG
London, United Kingdom, SW17 0QT
London, United Kingdom, W12 OHS
Manchester, United Kingdom, M20 4BX
Norwich, United Kingdom, NR4 7UY
Nottingham, United Kingdom, NG5 1PB
Oxford, United Kingdom, OX3 7LJ
Portsmouth, United Kingdom, PO6 3LY
Southampton, United Kingdom, SO16 6YD
Sutton, United Kingdom, SM2 5PT
Sutton, United Kingdom, SW3 6JJ
Swansea, United Kingdom, SA2 8QA
Swindon, United Kingdom, SN3 6BB
Truro, United Kingdom, TR1 3LJ
Sponsors and Collaborators
Hoffmann-La Roche
German Low Grade Lymphoma Study Group
Institute of Cancer Research, United Kingdom
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01332968     History of Changes
Other Study ID Numbers: BO21223
Study First Received: April 8, 2011
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Obinutuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 01, 2014