ClinicalTrials.gov
History of Changes for Study: NCT01332968
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
Latest version (submitted August 9, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 8, 2011 None (earliest Version on record)
2 May 18, 2011 Contacts/Locations, Study Status and Oversight
3 June 15, 2011 Contacts/Locations and Study Status
4 July 19, 2011 Contacts/Locations and Study Status
5 August 10, 2011 Recruitment Status, Contacts/Locations and Study Status
6 September 19, 2011 Contacts/Locations and Study Status
7 October 14, 2011 Contacts/Locations and Study Status
8 November 15, 2011 Study Status and Contacts/Locations
9 December 5, 2011 Contacts/Locations and Study Status
10 January 17, 2012 Contacts/Locations and Study Status
11 February 15, 2012 Study Status and Contacts/Locations
12 March 16, 2012 Contacts/Locations and Study Status
13 March 22, 2012 Contacts/Locations and Study Status
14 April 18, 2012 Contacts/Locations and Study Status
15 May 3, 2012 Study Status, Contacts/Locations, Study Description and Study Identification
16 May 29, 2012 Contacts/Locations, Eligibility, Study Description and Study Status
17 July 5, 2012 Contacts/Locations, Sponsor/Collaborators, Study Status, Arms and Interventions, Study Description and Study Identification
18 July 17, 2012 Contacts/Locations and Study Status
19 August 15, 2012 Study Status and Contacts/Locations
20 September 19, 2012 Contacts/Locations and Study Status
21 October 10, 2012 Contacts/Locations and Study Status
22 November 1, 2012 Contacts/Locations and Study Status
23 November 15, 2012 Contacts/Locations and Study Status
24 December 3, 2012 Study Status and Contacts/Locations
25 January 3, 2013 Contacts/Locations and Study Status
26 January 7, 2013 Contacts/Locations and Study Status
27 January 14, 2013 Contacts/Locations and Study Status
28 January 21, 2013 Contacts/Locations and Study Status
29 January 31, 2013 Contacts/Locations and Study Status
30 February 4, 2013 Contacts/Locations and Study Status
31 February 11, 2013 Contacts/Locations and Study Status
32 February 19, 2013 Contacts/Locations and Study Status
33 February 25, 2013 Contacts/Locations and Study Status
34 March 4, 2013 Contacts/Locations and Study Status
35 March 11, 2013 Contacts/Locations and Study Status
36 March 18, 2013 Contacts/Locations and Study Status
37 March 25, 2013 Contacts/Locations and Study Status
38 April 1, 2013 Contacts/Locations and Study Status
39 April 8, 2013 Contacts/Locations and Study Status
40 April 15, 2013 Contacts/Locations and Study Status
41 April 22, 2013 Contacts/Locations and Study Status
42 April 29, 2013 Contacts/Locations and Study Status
43 May 7, 2013 Study Status and Contacts/Locations
44 May 13, 2013 Contacts/Locations and Study Status
45 July 1, 2013 Contacts/Locations and Study Status
46 July 9, 2013 Contacts/Locations and Study Status
47 July 16, 2013 Contacts/Locations and Study Status
48 July 23, 2013 Contacts/Locations and Study Status
49 July 29, 2013 Contacts/Locations and Study Status
50 August 5, 2013 Study Status and Contacts/Locations
51 August 13, 2013 Contacts/Locations and Study Status
52 August 19, 2013 Contacts/Locations and Study Status
53 August 26, 2013 Contacts/Locations and Study Status
54 September 4, 2013 Study Status and Contacts/Locations
55 September 9, 2013 Contacts/Locations and Study Status
56 September 12, 2013 Study Status and Contacts/Locations
57 September 18, 2013 Contacts/Locations and Study Status
58 September 25, 2013 Contacts/Locations and Study Status
59 October 7, 2013 Contacts/Locations and Study Status
60 October 8, 2013 Contacts/Locations and Study Status
61 October 17, 2013 Contacts/Locations and Study Status
62 October 21, 2013 Contacts/Locations and Study Status
63 October 28, 2013 Contacts/Locations and Study Status
64 November 4, 2013 Contacts/Locations and Study Status
65 November 13, 2013 Contacts/Locations and Study Status
66 November 18, 2013 Contacts/Locations and Study Status
67 November 25, 2013 Contacts/Locations and Study Status
68 December 3, 2013 Study Status and Contacts/Locations
69 December 9, 2013 Contacts/Locations and Study Status
70 December 17, 2013 Contacts/Locations and Study Status
71 January 6, 2014 Contacts/Locations and Study Status
72 January 13, 2014 Contacts/Locations and Study Status
73 January 20, 2014 Contacts/Locations, Arms and Interventions, Sponsor/Collaborators and Study Status
74 January 27, 2014 Contacts/Locations and Study Status
75 February 3, 2014 Contacts/Locations and Study Status
76 February 10, 2014 Contacts/Locations and Study Status
77 February 17, 2014 Contacts/Locations, Sponsor/Collaborators and Study Status
78 February 24, 2014 Contacts/Locations and Study Status
79 March 3, 2014 Study Status and Contacts/Locations
80 March 14, 2014 Recruitment Status, Study Status, Contacts/Locations and Study Design
81 March 17, 2014 Study Status
82 March 24, 2014 Study Status
83 March 31, 2014 Recruitment Status, Study Status, Contacts/Locations and Study Design
84 April 7, 2014 Study Status and Contacts/Locations
85 April 14, 2014 Contacts/Locations and Study Status
86 April 22, 2014 Contacts/Locations and Study Status
87 April 28, 2014 Contacts/Locations and Study Status
88 May 5, 2014 Study Status and Contacts/Locations
89 May 12, 2014 Study Status
90 May 19, 2014 Contacts/Locations and Study Status
91 May 26, 2014 Contacts/Locations and Study Status
92 June 23, 2014 Study Status, Contacts/Locations and Study Description
93 June 30, 2014 Contacts/Locations and Study Status
94 July 7, 2014 Study Status
95 July 14, 2014 Contacts/Locations and Study Status
96 July 21, 2014 Recruitment Status, Study Status, Contacts/Locations and Study Design
97 August 4, 2014 Study Status
98 August 26, 2014 Arms and Interventions and Study Status
99 September 22, 2014 Study Status
100 October 6, 2014 Study Status
101 October 13, 2014 Study Status
102 October 20, 2014 Study Status
103 November 3, 2014 Study Status and Contacts/Locations
104 November 10, 2014 Contacts/Locations and Study Status
105 November 24, 2014 Contacts/Locations and Study Status
106 December 1, 2014 Study Status
107 December 8, 2014 Contacts/Locations and Study Status
108 December 15, 2014 Contacts/Locations and Study Status
109 December 23, 2014 Contacts/Locations and Study Status
110 January 6, 2015 Study Status
111 January 12, 2015 Contacts/Locations, Study Description and Study Status
112 January 19, 2015 Contacts/Locations, Study Description and Study Status
113 February 5, 2015 Contacts/Locations, Study Status and Study Description
114 February 19, 2015 Study Status
115 February 23, 2015 Contacts/Locations and Study Status
116 March 2, 2015 Study Status
117 March 9, 2015 Contacts/Locations and Study Status
118 March 16, 2015 Study Status
119 April 2, 2015 Contacts/Locations and Study Status
120 May 5, 2015 Study Status
121 May 11, 2015 Contacts/Locations and Study Status
122 June 1, 2015 Study Status
123 July 1, 2015 Study Status
124 July 31, 2015 Contacts/Locations and Study Status
125 August 17, 2015 Study Status
126 September 1, 2015 Study Status and Contacts/Locations
127 October 1, 2015 Study Status
128 November 2, 2015 Contacts/Locations and Study Status
129 December 1, 2015 Study Status
130 February 1, 2016 Study Status and Contacts/Locations
131 March 1, 2016 Study Status and Contacts/Locations
132 April 2, 2016 Study Status
133 May 4, 2016 Study Status
134 June 1, 2016 Study Status and Contacts/Locations
135 July 1, 2016 Contacts/Locations and Study Status
136 August 1, 2016 Study Status
137 September 1, 2016 Study Status
138 May 5, 2017 Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations, Study Identification, Results, Eligibility and Study Description
139 June 9, 2017 Study Status and Contacts/Locations
140 September 8, 2017 Study Status and Contacts/Locations
141 December 1, 2017 Study Status and Contacts/Locations
142 April 12, 2018 Study Status and Contacts/Locations
143 July 3, 2018 Contacts/Locations and Study Status
144 September 20, 2018 Study Status and Contacts/Locations
145 December 17, 2018 Contacts/Locations and Study Status
146 March 28, 2019 Study Status
147 July 2, 2019 Contacts/Locations and Study Status
148 September 27, 2019 Study Status, Outcome Measures and Contacts/Locations
149 December 31, 2019 Contacts/Locations and Study Status
150 March 30, 2020 Study Status and Contacts/Locations
151 June 28, 2020 Contacts/Locations and Study Status
152 March 24, 2021 Contacts/Locations and Study Status
153 May 11, 2021 Study Status
154 June 21, 2021 Contacts/Locations and Study Status
155 October 19, 2021 Recruitment Status, Study Status and Contacts/Locations
156 December 14, 2021 Study Status and Contacts/Locations
157 December 16, 2021 Study Status and Contacts/Locations
158 April 27, 2022 Study Status and Contacts/Locations
159 August 9, 2022 Adverse Events, Outcome Measures, Baseline Characteristics, Participant Flow, Study Status and Document Section
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Study NCT01332968
Submitted Date:  April 8, 2011 (v1)
Open or close this module Study Identification
Unique Protocol ID: BO21223
Brief 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
Official 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.
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2011
Overall Status: Not yet recruiting
Study Start: July 2011
Primary Completion: July 2023 [Anticipated]
Study Completion: July 2023 [Anticipated]
First Submitted: April 8, 2011
First Submitted that
Met QC Criteria:		 April 8, 2011
First Posted: April 11, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:		 April 8, 2011
Last Update Posted: April 11, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Hoffmann-La Roche
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: This open-label, randomized study will assess the efficacy and safety of RO5072759 (GA101) in combination with chemotherapy compared to MabThera/Rituxan (rituximab) with chemotherapy in patients with untreated advanced indolent non-Hodgkin's lymphoma. Patients will be randomized to receive 6-8 cycles (28 or 21 day cycles) of chemotherapy plus either RO5072759 1000 mg intravenously (iv) on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2 to 6 or 8, or MabThera/Rituxan 375 mg/m2 iv on Day 1 of Cycle 1 to 6 or 8. Patients who respond to treatment will continue to receive monotherapy with either RO5072759 1000 mg iv or MabThera/Rituxan 375 mg/m2 every 2 months until disease progression for up to 2 years. Anticipated time on study treatment is up to approximately 2.5 years.
Detailed Description:
Open or close this module Conditions
Conditions: Non-Hodgkin's Lymphoma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 1400 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: A Drug: rituximab [MabThera/Rituxan]
375 mg/m2 iv on Day 1 of Cycles 1-8 (21-day cycles) or Cycles 1-6 (28-day cycles); followed by 375 mg/m2 iv every 2 months in responders until disease progression, for up to 2 years
Drug: chemotherapy
8 cycles (21-day cycles) or 6 cycles (28-day cycles)
Experimental: B Drug: RO5072759
1000 mg iv on Days 1, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2-8 (21-day cycles) or Cycles 2-6 (28-day cycles); followed by 1000 mg iv every 2 months in responders until disease progression, for up to 2 years
Other Names:
  • GA101
Drug: chemotherapy
8 cycles (21-day cycles) or 6 cycles (28-day cycles)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression-free survival in patients with follicular lymphoma, investigator-assessed according to the Revised Response Criteria for Malignant Lymphoma
[ Time Frame: up to approximately 7.5 years ]
Secondary Outcome Measures:
1. Progression-free survival in the overall study population, investigator-assessed
[ Time Frame: up to approximately 7.5 years ]
2. Progression-free survival, Independent Review Committee - assessed
[ Time Frame: up to approximately 7.5 years ]
3. Response (overall response and complete response), investigator-assessed
[ Time Frame: 168 days ]
4. Response (overall response and complete response), Independent Review Committee - assessed
[ Time Frame: 168 days ]
5. Overall survival
[ Time Frame: up to approximately 10.7 years ]
6. Event-free survival
[ Time Frame: up to approximately 7.5 years ]
7. Disease-free survival
[ Time Frame: up to approximately 7.5 years ]
8. Duration of response
[ Time Frame: up to approximately 7.5 years ]
9. Time to next anti-lymphoma treatment
[ Time Frame: up to approximately 10.7 years ]
10. Safety: Incidence of adverse events
[ Time Frame: up to approximately 10.7 years ]
11. Patient-reported outcomes (Functional Assessment of Cancer Therapy for Lymphoma scale, EuroQol EQ-5D questionnaire)
[ Time Frame: up to approximately 7.5 years ]
12. Medical resource utilization (hospitalizations, subsequent drug therapies, medical and surgical procedures)
[ Time Frame: up to approximately 7.5 years ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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, requiring treatment
  • 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
  • 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
  • Positive for HIV, HTLV1, hepatitis C or chronic hepatitis B
Open or close this module Contacts/Locations
Central Contact Person: Please reference Study ID Number: BO21223
Telephone: 888-662-6728 (U.S. Only)
Email: genentechclinicaltrials@druginfo.com
Study Officials: Clinical Trials
Study Director
Hoffmann-La Roche
Locations: United States, Arizona
Chandler, Arizona, United States, 85224
United States, California
Bellflower, California, United States, 90706
La Jolla, California, United States, 92093
Orange, California, United States, 92868
Vallejo, California, United States, 94589
United States, Connecticut
Stamford, Connecticut, United States, 06902
United States, Idaho
Post Falls, Idaho, United States, 83854
United States, Illinois
Galesburg, Illinois, United States, 61401
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas City, Kansas, United States, 66205
United States, Maryland
Baltimore, Maryland, United States, 21215
United States, Missouri
Springfield, Missouri, United States, 65807
United States, New Mexico
Farmington, New Mexico, United States, 87401
United States, Ohio
Middletown, Ohio, United States, 45042
United States, Oregon
Portland, Oregon, United States, 97225
United States, Texas
San Antonio, Texas, United States, 78229
United States, Washington
Tacoma, Washington, United States, 98405
Germany
Burgwedel, Germany, 30938
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services