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

• Register: EUCTR
• Last refreshed on: 19 February 2024
• Main ID: EUCTR2010-024132-41-HU
• Date of registration: 30/05/2011
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd.
• Public title: 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
• 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 - GALLIUM
• Date of first enrolment: 05/09/2011
• Target sample size: 1400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-024132-41
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Czech Republic, El Salvador, Finland, France, Germany, Guatemala, Hungary, Ireland, Italy, Japan, Macedonia, the former Yugoslav Republic of, Mexico, Panama, Peru, Russian Federation, South Africa, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

Key inclusion & exclusion 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
- 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"



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

INDOLENT NON-HODGKIN'S LYMPHOMA
MedDRA version: 14.1 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: RO5072759
Product Code: GA101
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-

Primary Outcome(s)

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

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 (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.

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

Timepoint(s) of evaluation of this end point: up to approximately 7.5 years

Secondary Outcome(s)

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

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)

Secondary ID(s)

2010-024132-41-BE

BO21223

Source(s) of Monetary Support

F.Hoffmann-La Roche AG

Ethics review

Status: Approved
Approval date: 03/08/2011
Contact:

Results

• Results available: Yes
• Date Posted: 16/03/2017
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-024132-41/results