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) | Not Recruiting
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)

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Non-Hodgkin's Lymphoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Not Recruiting
Recruitment Status
NCT01332968
Primary Trial ID Number
Summary
This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to MabThera/Rituxan (rituximab) with chemotherapy followed by obinutuzumab or MabThera/Rituxan maintenance in patients with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, patients achieving response (CR or PR) will go on to a maintenance period thereby continuing on their 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 patients will be followed for 5 years until progression. After progression, patients 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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : RO5072759, Drug : chemotherapy, Drug : rituximab [MabThera/Rituxan]

Study Arm Groups : B, A, B, A

Intervention Type
See Interventions above
Primary Outcome Measures
  • Progression-free survival in patients with follicular lymphoma, investigator-assessed according to the Revised Response Criteria for Malignant Lymphoma; up to approximately 7.5 years
Secondary Outcome Measures
  • Progression-free survival in the overall study population, investigator-assessed; up to approximately 7.5 years; Progression-free survival, Independent Review Committee - assessed; up to approximately 7.5 years; Response (overall response and complete response), investigator-assessed; 168 days; Response (overall response and complete response), Independent Review Committee - assessed; 168 days; Overall survival; up to approximately 10.7 years; Event-free survival; up to approximately 7.5 years; Disease-free survival; up to approximately 7.5 years; Duration of response; up to approximately 7.5 years; Time to next anti-lymphoma treatment; up to approximately 10.7 years; Safety: Incidence of adverse events; up to approximately 10.7 years; Patient-reported outcomes (Functional Assessment of Cancer Therapy for Lymphoma scale, EuroQol EQ-5D questionnaire); up to approximately 7.5 years; Medical resource utilization (hospitalizations, subsequent drug therapies, medical and surgical procedures); up to approximately 7.5 years
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Christie Hospital NHS Foundation Trust
Manchester
M20 4BX
Oxford Transplant Centre, Churchill Hospital
Oxford
Oxfordshire
OX3 7LJ
St. James University Hospital
Leeds
LS9 7TF
Southampton General Hospital
Southampton
England
SO16 6YD
London
NW3 2QG
Norfolk and Norwich University Hospital
Norwich
England
NR4 7UY
King's College Hospital
London
England
SE5 9RS
Research Site
Truro
Cornwall
TR1 3LJ
St George's Healthcare NHS Trust
London
SW17 0QT
Birmingham
B15 2TH
Research Site
Sutton
Surrey
SM2 5PT
Leicester Royal Infirmary
Leicester
England
LE1 5WW
Addenbrookes Hospital
Cambridge
CB2 0QQ
Aberdeen Royal Infirmary
Aberdeen
Scotland
AB25 2ZN
Nottingham University Hospitals, City Campus
Nottingham
NG5 1PB
Edinburgh Cancer Centre at Western General Hospital
Edinburgh
Scotland
EH4 2XU
Portsmouth Hospitals NHS Trust
Portsmouth
PO6 3LY
GSK Investigational Site
London
EC1M 6BQ
Glasgow
G12 0YN
Novartis Investigative Site
Cardiff
CF14 2TL
Singleton Hospital
Swansea
Sketty Lane
SA2 8QA
Royal Bournemouth General Hospital
Bournemouth
BH7 7DW
Bristol Haematology & Oncology Centre
Bristol
BS2 8ED
Hammersmith Hospital
London
England
W12 OHS
Novartis Investigative Site
Great Yarmouth
NR31 6LA
Novartis Investigative Site
Swindon
SN3 6BB
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
East Kent Hospitals University Foundation Trust, Kent & Canterbury Hospital
Canterbury
CT1 3NG
Cottingham
HU16 5JG
Sutton
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
United States, Australia, Belgium, Canada, China, Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, Japan, Russian Federation, Spain, Sweden, Taiwan, United Kingdom
Scientific 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.
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

Jul 2011

Recruitment End Date

Feb 2017

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

08 Apr 2011

Last Updated

17 Aug 2015