A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Ri... | Not Recruiting
A Study of Obinutuzumab (RO5072759)... | Not Recruiting
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)

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Medical Conditions
  • Non-Hodgkin's Lymphoma
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT01332968

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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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Obinutuzumab, Drug : Cyclophosphamide, Drug : Doxorubicin, Drug : Vincristine, Drug : Prednisone, Drug : Bendamustine, Drug : Rituximab

Study Arm Groups : Obinutuzumab+Chemotherapy, Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy, Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy, Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy, Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy, Rituximab+Chemotherapy, Obinutuzumab+Chemotherapy, Rituximab+Chemotherapy

Intervention Type
See Interventions above
Primary Outcome Measures
    Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed; Baseline up to data cut-off (up to approximately 4 years and 7 months)
Secondary Outcome Measures
    Progression-Free Survival in the Overall Study Population, Investigator-Assessed; Baseline up to data cut-off (up to approximately 4 years and 7 months); Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed; Baseline up to data cut-off (up to approximately 4 years and 7 months); Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC); Baseline up to data cut-off (up to approximately 4 years and 7 months); Overall Response (Follicular Lymphoma Population), Investigator-Assessed; Baseline up to end of induction period (up to approximately 7 months); Overall Response (Overall Study Population), Investigator-Assessed; Baseline up to end of induction period (up to approximately 7 months); Complete Response (Follicular Lymphoma Population), Investigator-Assessed; Baseline up to end of induction period (up to approximately 7 months); Complete Response (Overall Study Population), Investigator-Assessed; Baseline up to end of induction period (up to approximately 7 months); Overall Response (Follicular Lymphoma Population), IRC-Assessed; Baseline up to end of induction period (up to approximately 7 months); Overall Response (Overall Study Population), IRC-Assessed; Baseline up to end of induction period (up to approximately 7 months); Complete Response (Follicular Lymphoma Population), IRC-Assessed; Baseline up to end of induction period (up to approximately 7 months); Complete Response (Overall Study Population), IRC-Assessed; Baseline up to end of induction period (up to approximately 7 months)]; Overall Survival (Follicular Lymphoma Population); Baseline up to data cut-off (up to approximately 4 years and 7 months; Overall Survival (Overall Study Population); Baseline up to data cut-off (up to approximately 4 years and 7 months; Event-Free Survival (Follicular Lymphoma Population); Baseline up to data cut-off (up to approximately 4 years and 7 months); Event-Free Survival (Overall Study Population); Baseline up to data cut-off (up to approximately 4 years and 7 months; Disease-Free Survival (Follicular Lymphoma Population); From first occurrence of documented CR to data cut-off (up to approximately 4 years and 7 months); Disease-Free Survival (Overall Study Population); From first occurrence of documented CR to data cut-off (up to approximately 4 years and 7 months; Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed; From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months; Duration of Response (DOR) (Overall Study Population), Investigator-Assessed; From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months); Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population); Baseline up to data cut-off (up to approximately 4 years and 7 months; Time to Next Anti-Lymphoma Treatment (Overall Study Population); Baseline up to data cut-off (up to approximately 4 years and 7 months); Percentage of Participants With Adverse Events; Baseline up to data cut-off (up to approximately 4 years and 7 months); Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population); Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months); Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population); Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months); Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population); Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months); Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population); Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months); Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase; 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 4 years and 7 months); Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase; 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 4 years and 7 months); Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase; 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 4 years and 7 months)
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    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

    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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Kent and Canterbury Hospital
Canterbury
England
CT1 3NG
Leicester Royal Infirmary
Leicester
England
LE1 5WW
St. George's Hospital
London
England
SW17 0QT
Southampton General Hospital
Southampton
England
SO16 6YD
Royal Marsden - Surrey
Sutton
England
SM2 5PT
Aberdeen Royal Infirmary
Aberdeen
Scotland
AB25 2ZN
Edinburgh Cancer Centre at Western General Hospital
Edinburgh
Scotland
EH4 2XU
Velindre Cancer Center at Velindre Hospital
Cardiff
Wales
CF14 2TL
London
EC1A 7BE
South West Wales Cancer Institute
Sketty
Wales
SA2 8QA
GSK Investigational Site
Cambridge
CB2 0QQ
Birmingham
B15 2TH
King's College Hospital
London
SE5 9RS
St. James University Hospital, Department of Neurology
Leeds
LS9 7TF
Nottingham
Nottinghamshire
NG5 1PB
Manchester
M20 4QL
Truro
TR1 3LJ
Norwich
NR4 7UY
Swindon
SN3 6BB
Oxford
OX3 7LJ
Bristol
BS2 8ED
Royal Bournemouth Hospital
Bournemouth
Dorset
BH7 7DW
Pfizer Investigational Site
London
W12 OHS
Glasgow
G12 0YN
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
Portsmouth
Hampshire
PO6 3LY
Cottingham
HU16 5JG
Site Reference ID/Investigator# 125696
Great Yarmouth
NR31 6LA
UCH Macmillan Cancer Centre Huntley Street
London
WC1E 6AG
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Harlow
CM20 1QX
London
SW3 6JJ
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Belgium, Canada, China, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Japan, Russian Federation, Spain, Sweden, Taiwan, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
EudraCT Number
Not available for this trial
Funder(s)
  • German Low Grade Lymphoma Study Group
  • Institute of Cancer Research, United Kingdom
Other Study ID Numbers
BO21223
Sponsor(s)
Hoffmann-La Roche
Key Dates

Recruitment Start Date

Aug 2011

Recruitment End Date

Feb 2016

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

08 Apr 2011

Date updated in source

09 Jun 2017