Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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8 October 2021 |
Main ID: |
EUCTR2010-024132-41-BE |
Date of registration:
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28/04/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study of RO5072759 (GA101) 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
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Scientific title:
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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 - GALLIUM |
Date of first enrolment:
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14/06/2011 |
Target sample size:
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1400 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-024132-41 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Bosnia and Herzegovina
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Brazil
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Canada
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Chile
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China
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Colombia
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Czech Republic
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El Salvador
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Finland
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France
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Germany
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Guatemala
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Hungary
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Ireland
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Italy
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Japan
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Macedonia, the former Yugoslav Republic of
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Mexico
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Panama
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Peru
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Russian Federation
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South Africa
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Spain
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Sweden
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Taiwan
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F. Hoffmann-La Roche Ltd |
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F. Hoffmann-La Roche Ltd |
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Key inclusion & exclusion criteria
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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
- 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" Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 504 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 252
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
- History of other prior malignancy with the exception of curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or cacinoma in situ of the cervix at any time prior to the study. Other cancers not specified above wich have been curatively treated by surgary alone and from which the subject is disease-free for =5years without further treatment
- Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1
- Positive for HIV, HTLV1, hepatitis C or chronic hepatitis B
- Patients with a history of confirmed PML
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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INDOLENT NON-HODGKIN'S LYMPHOMA MedDRA version: 22.0
Level: PT
Classification code 10029547
Term: Non-Hodgkin's lymphoma
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Intervention(s)
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Trade Name: Gazyvaro Product Name: Obinutuzumab Product Code: GA101/RO5072759 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: obinutuzumab CAS Number: 949142-50-1 Current Sponsor code: RO5072759/F06 Other descriptive name: GA101 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000-
Trade Name: MabThera Product Name: rituximab Product Code: RO 0452294 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Current Sponsor code: Ro 045-2294/V01 Other descriptive name: MabThera Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-
Trade Name: MabThera Product Name: rituximab Product Code: RO 0452294 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Current Sponsor code: Ro 045-2294/V01 Other descriptive name: MabThera Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-
Product Code: RO5469113 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: BENDAMUSTINE HYDROCHLORIDE CAS Number: 3543757 Current Sponsor code: RO5469113 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
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Primary Outcome(s)
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Main Objective: Progression-free survival in patients with follicular lymphoma, investigator-assessed according to the Revised Response Criteria for Malignant Lymphoma up to 7.5 years
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Primary end point(s): The primary efficacy endpoint, PFS in patients with follicular lymphoma, is defined as the time from randomization to the first occurrence of progression or relapse as assessed by the investigator according to the Revised Response Criteria for Malignant Lymphoma and additional response criteria for MZL (Cheson et al. 2007), or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment, or if no tumor assessments were performed after the baseline visit, at the time of randomization.
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Secondary Objective: PFS in the overall study population, investigator-assessed up to approximately 7.5 years PFS in the overall study population, Independent Review Committee assessed up to approximately 7.5 years Response (OR and CR) assessed by the investigator up to 168 days Response (OR and CR) assessed by Independent Review Committee 168 days OS 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 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
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Timepoint(s) of evaluation of this end point: up to approximately 7.5 years
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 84 days for induction
168 day for Response
7.5 to 10.7 years for all other end points
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Secondary end point(s): Progression-free survival in the overall study population, investigator-assessed
Progression-free survival, Independent Review Committee - assessed
Response (overall response and complete response), investigator-assessed
Response (overall response and complete response), Independent Review Committee - assessed
Overall survival
Event-free survival
Disease-free survival
Duration of response
Time to next anti-lymphoma treatment
Safety: Incidence of adverse events
Patient-reported outcomes (Functional Assessment of Cancer Therapy for Lymphoma scale, EuroQol EQ-5D questionnaire)
Medical resource utilization (hospitalizations, subsequent drug therapies, medical and surgical procedures)
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Source(s) of Monetary Support
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F.Hoffmann-La Roche AG
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Ethics review
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Status: Approved
Approval date: 07/06/2011
Contact:
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