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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28 February 2019 |
Main ID: |
EUCTR2009-015504-25-GB |
Date of registration:
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18/06/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma
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Scientific title:
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An Open Label, Multicenter, randomized, phase III study to investigate the efficacy and safety of Bendamustine compared with Bendamustine + Obinutuzumab RO5072759 (GA101) in patients with Rituximab-refractory, indolent Non-Hodgkin’s Lymphoma - GADOLIN |
Date of first enrolment:
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17/08/2010 |
Target sample size:
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410 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015504-25 |
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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Austria
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Belgium
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Canada
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Czech Republic
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France
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Germany
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Hungary
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Italy
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Japan
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Netherlands
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Russian Federation
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Spain
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Sweden
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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
CH-4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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Genentech Inc. c/o 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
CH-4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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Genentech Inc. c/o F. Hoffmann-La Roche Ltd. |
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Key inclusion & exclusion criteria
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Inclusion criteria: – History of histologically documented, CD20+, indolent NHL
– Refractory to any previous regimen containing rituximab
– Previously treated with a maximum of four unique chemotherapy containing treatment regimens
– All patients must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension by CT scan) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 246 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 164
Exclusion criteria: – Prior use of any monoclonal antibody (other than anti-CD20) within 3 months
– Chemotherapy or other investigational therapy within 28 days
– Prior treatment with bendamustine within 2 years of the start of cycle 1
– Prior allogeneic stem cell transplant
– History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (e.g., patients in whom re-dosing with rituximab would be contraindicated for safety reasons)
– History of sensitivity to mannitol
– Central nervous system lymphoma, prior DLBCL, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
– History of other malignancy that could affect compliance with the protocol or interpretation of results
– Patients with a history of confirmed PML
– Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
– Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 4 weeks
– Vaccination with a live vaccine a minimum of 28 days prior to randomization
– Recent major surgery (within 4 weeks), other than for diagnosis
– Presence of positive test results for Hepatitis B or Hepatitis C
– Known history of HIV seropositive status
– Positive test results for human T-lymphotropic virus type I (HTLV 1) virus in endemic countries
– Women who are pregnant or lactating
– Agreement to use an effective form of contraception for the duration of the study
– Ongoing corticosteroid use >30 mg/day prednisone or equivalent
– Radiation therapy within 42 days prior to the start of cycle 1
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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CD20+, indolent NHL
MedDRA version: 20.0
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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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Trade Name: Gazyvaro Product Name: Obinutuzumab Product Code: RO 5072759/F06 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: obinutuzumab CAS Number: 949142-50-1 Current Sponsor code: RO5072759 Other descriptive name: GA101 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000-
Trade Name: Ribomustin Product Code: RO5469113 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: bendamustine hydrochloride CAS Number: 3543-75-7 Current Sponsor code: RO5469113 Other descriptive name: n/a Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
Product Code: RO5469113 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: bendamustine hydrochloride CAS Number: 3543-75-7 Current Sponsor code: RO5469113 Other descriptive name: n/a Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
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Primary Outcome(s)
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Primary end point(s): 1. Progression-free survival
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Secondary Objective: •To compare PFS as assessed by the investigator •To compare OS between study arms •To evaluate in each study arm and compare between study arms the following: overall response rate and CRR at the Study Treatment Completion/Early Study Treatment Termination Visit; best ORR achieved during treatment or within 12 months of the start of treatment; disease-free survival in CR patients; duration of response in patients with CR and PR •To compare event-free survival between the two study arms •To evaluate and compare the safety profiles of patients treated with the combination of GA101 + bendamustine and bendamustine alone •To characterize the pharmacokinetics of GA101 in combination with bendamustine and evaluate for drug-drug interactions by comparing the pharmacokinetics of the combination with the pharmacokinetics of bendamustine alone •To analyze pharmacoeconomics (medical resource utilization) in both arms of the study •To assess patient-reported outcomes in both treatment arms
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Timepoint(s) of evaluation of this end point: 1. Time from randomization to first occurrence of progression or relapse, as assessed by the IRF, or death from any cause.
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Main Objective: To evaluate clinical benefit in terms of PFS, as assessed by an IRF, for GA101 when used in combination with bendamustine compared with bendamustine alone in patients with indolent NHL refractory to prior rituximab-containing therapy
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Secondary Outcome(s)
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Secondary end point(s): 1. Overall survival
2. Complete response (CR) and overall response (CR or partial response [PR])
3. Best response
4. PFS as assessed by Investigator
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Timepoint(s) of evaluation of this end point: 1. Time from randomization to death
2. At 6 months
3. Up to 12 months after start of treatment
4. Prior to cycle 4, approximately 28-42 days after cycle 6, every 2 months (3 months for CT scans) for 24 months after the first 6 months of treatment, and every 6 months thereafter for an additional 2 years or until progression
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Secondary ID(s)
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GAO4753g
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2009-015504-25-CZ
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Source(s) of Monetary Support
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Genentech Inc. c/o F. Hoffmann-La Roche Ltd.
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Ethics review
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Status: Approved
Approval date:
Contact:
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