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)
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Collaborators:
German Low Grade Lymphoma Study Group
Institute of Cancer Research, United Kingdom
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01332968
First received: April 8, 2011
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: RO5072759 Drug: rituximab [MabThera/Rituxan] Drug: chemotherapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival in the overall study population, investigator-assessed [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
- Progression-free survival, Independent Review Committee - assessed [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
- Response (overall response and complete response), investigator-assessed [ Time Frame: 168 days ] [ Designated as safety issue: No ]
- Response (overall response and complete response), Independent Review Committee - assessed [ Time Frame: 168 days ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: up to approximately 10.7 years ] [ Designated as safety issue: No ]
- Event-free survival [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
- Disease-free survival [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
- Time to next anti-lymphoma treatment [ Time Frame: up to approximately 10.7 years ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: up to approximately 10.7 years ] [ Designated as safety issue: No ]
- Patient-reported outcomes (Functional Assessment of Cancer Therapy for Lymphoma scale, EuroQol EQ-5D questionnaire) [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
- Medical resource utilization (hospitalizations, subsequent drug therapies, medical and surgical procedures) [ Time Frame: up to approximately 7.5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1400 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | March 2022 |
| Estimated Primary Completion Date: | March 2022 (Final data collection date for primary outcome measure) |
| 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
CHOP (6 cycles of 21 days), CVP (8 cycles of 21 days), Bendamustine (6 cycles of 28 days). Patients with follicular lymphoma are receiving either CHOP, CVP or Bendamustine as background chemotherapy as selected by each participating site at study start. Background chemotherapy for patients with non-follicular lymphoma will be chosen by the site individually for each patient.
|
| 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 Name: GA101
Drug: chemotherapy
CHOP (6 cycles of 21 days), CVP (8 cycles of 21 days), Bendamustine (6 cycles of 28 days). Patients with follicular lymphoma are receiving either CHOP, CVP or Bendamustine as background chemotherapy as selected by each participating site at study start. Background chemotherapy for patients with non-follicular lymphoma will be chosen by the site individually for each patient.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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 (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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332968
Hide Study Locations
Contacts
| Contact: Please reference Study ID Number: BO21223 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Hide Study LocationsLocations
| United States, Arkansas | |
| Not yet recruiting | |
| Fayetteville, Arkansas, United States, 72703 | |
| United States, California | |
| Not yet recruiting | |
| Orange, California, United States, 92868 | |
| United States, Idaho | |
| Recruiting | |
| Post Falls, Idaho, United States, 83854 | |
| United States, Illinois | |
| Recruiting | |
| Galesburg, Illinois, United States, 61401 | |
| Not yet recruiting | |
| Maywood, Illinois, United States, 60153 | |
| United States, Iowa | |
| Not yet recruiting | |
| Sioux City, Iowa, United States, 51108 | |
| United States, Kansas | |
| Active, not recruiting | |
| Westwood, Kansas, United States, 66206 | |
| United States, Missouri | |
| Active, not recruiting | |
| Springfield, Missouri, United States, 65807 | |
| United States, Montana | |
| Recruiting | |
| Missoula, Montana, United States, 59802 | |
| United States, New Mexico | |
| Active, not recruiting | |
| Farmington, New Mexico, United States, 87401 | |
| United States, Oregon | |
| Active, not recruiting | |
| Portland, Oregon, United States, 97225 | |
| United States, Washington | |
| Active, not recruiting | |
| Tacoma, Washington, United States, 98405 | |
| Australia | |
| Recruiting | |
| East Melbourne, Australia, 3002 | |
| Recruiting | |
| Fitzroy, Australia, 3065 | |
| Recruiting | |
| Melbourne, Australia, 3168 | |
| Recruiting | |
| Melbourne, Australia, 3084 | |
| Recruiting | |
| Perth, Australia, 6000 | |
| Active, not recruiting | |
| Sydney, Australia, 2139 | |
| Recruiting | |
| Sydney, Australia, 2145 | |
| Recruiting | |
| Woolloongabba, Australia, 4102 | |
| Belgium | |
| Active, not recruiting | |
| Gent, Belgium, 9000 | |
| Active, not recruiting | |
| Kortrijk, Belgium, 8500 | |
| Active, not recruiting | |
| Leuven, Belgium, 3000 | |
| Brazil | |
| Not yet recruiting | |
| Campinas, Brazil, 13083-970 | |
| Not yet recruiting | |
| Florianopolis, Brazil, 88034-000 | |
| Not yet recruiting | |
| Porto Alegre, Brazil, 90610-000 | |
| Not yet recruiting | |
| Sao Paulo, Brazil, 08270-070 | |
| Not yet recruiting | |
| Sao Paulo, Brazil, 01236-030 | |
| Not yet recruiting | |
| São Paulo, Brazil, 04039-901 | |
| Canada, Alberta | |
| Active, not recruiting | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Active, not recruiting | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, New Brunswick | |
| Recruiting | |
| Moncton, New Brunswick, Canada, E1C 8X3 | |
| Canada, Ontario | |
| Recruiting | |
| East York, Ontario, Canada, M4C 3E7 | |
| Active, not recruiting | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Active, not recruiting | |
| Toronto, Ontario, Canada, M9N 1N8 | |
| Active, not recruiting | |
| Toronto, Ontario, Canada, M4P 2K9 | |
| Canada, Quebec | |
| Recruiting | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| China | |
| Recruiting | |
| Beijing, China, 100142 | |
| Not yet recruiting | |
| Beijing, China, 100034 | |
| Recruiting | |
| Beijing, China, 100853 | |
| Recruiting | |
| Beijing, China, 100021 | |
| Recruiting | |
| Changchun, China, 130021 | |
| Not yet recruiting | |
| Fuzhou, China, 350014 | |
| Not yet recruiting | |
| Fuzhou, China, 350001 | |
| Active, not recruiting | |
| Guangzhou, China, 510060 | |
| Not yet recruiting | |
| Guangzhou, China, 510080 | |
| Recruiting | |
| Harbin, China, 150081 | |
| Not yet recruiting | |
| Nanjing, China, 210009 | |
| Not yet recruiting | |
| Nanjing, China, 210008 | |
| Not yet recruiting | |
| Shanghai, China, 200025 | |
| Recruiting | |
| Shanghai, China, 200032 | |
| Not yet recruiting | |
| Shenyang, China, 110001 | |
| Not yet recruiting | |
| Suzhou, China, 215006 | |
| Recruiting | |
| Wuhan, China, 430023 | |
| Recruiting | |
| Wuhan, China, 430022 | |
| Czech Republic | |
| Active, not recruiting | |
| Brno, Czech Republic, 639 00 | |
| Recruiting | |
| Hradec Kralove, Czech Republic, 500 05 | |
| Active, not recruiting | |
| Praha 2, Czech Republic, 128 08 | |
| Finland | |
| Recruiting | |
| Helsinki, Finland, 00029 | |
| Not yet recruiting | |
| Tampere, Finland, 36280 | |
| France | |
| Recruiting | |
| Angers, France, 49933 | |
| Recruiting | |
| Brest, France, 29609 | |
| Recruiting | |
| Clermont-ferrand, France, 63003 | |
| Recruiting | |
| Lemans, France, 72000 | |
| Recruiting | |
| Marseille, France, 13005 | |
| Recruiting | |
| Montpellier, France, 34295 | |
| Not yet recruiting | |
| Perpignan, France, 66046 | |
| Germany | |
| Terminated | |
| Amberg, Germany, 92224 | |
| Active, not recruiting | |
| Berlin, Germany, 14195 | |
| Not yet recruiting | |
| Bremen, Germany, 28239 | |
| Active, not recruiting | |
| Chemnitz, Germany, 09113 | |
| Active, not recruiting | |
| Dessau, Germany, 06822 | |
| Recruiting | |
| Dresden, Germany, 01307 | |
| Active, not recruiting | |
| Dresden, Germany, 01307 | |
| Active, not recruiting | |
| Erfurt, Germany, 99089 | |
| Not yet recruiting | |
| Eschweiler, Germany, 52249 | |
| Recruiting | |
| Frankfurt, Germany, 60596 | |
| Active, not recruiting | |
| Freiburg, Germany, 79106 | |
| Active, not recruiting | |
| Greifswald, Germany, 17475 | |
| Active, not recruiting | |
| Göttingen, Germany, 37075 | |
| Active, not recruiting | |
| Hagen, Germany, 58095 | |
| Active, not recruiting | |
| Hannover, Germany, 30171 | |
| Active, not recruiting | |
| Heidelberg, Germany, 69120 | |
| Recruiting | |
| Heidelberg, Germany, 69115 | |
| Terminated | |
| HOF, Germany, 95028 | |
| Active, not recruiting | |
| Homburg/saar, Germany, 66424 | |
| Not yet recruiting | |
| Idar-oberstein, Germany, 55743 | |
| Active, not recruiting | |
| Jena, Germany, 07747 | |
| Active, not recruiting | |
| Kiel, Germany, 24116 | |
| Not yet recruiting | |
| Koblenz, Germany, 56068 | |
| Active, not recruiting | |
| Köln, Germany, 50924 | |
| Recruiting | |
| Landshut, Germany, 84028 | |
| Recruiting | |
| Lebach, Germany, 66822 | |
| Recruiting | |
| Leipzig, Germany, 04129 | |
| Recruiting | |
| Ludwigshafen, Germany, 67063 | |
| Recruiting | |
| Magdeburg, Germany, 39120 | |
| Terminated | |
| Magdeburg, Germany, 39130 | |
| Not yet recruiting | |
| Magedburg, Germany, 39104 | |
| Active, not recruiting | |
| Mainz, Germany, 55101 | |
| Active, not recruiting | |
| Mannheim, Germany, 68161 | |
| Recruiting | |
| Mannheim, Germany, 68167 | |
| Recruiting | |
| Muenchen, Germany, 81377 | |
| Not yet recruiting | |
| Mutlangen, Germany, 73557 | |
| Active, not recruiting | |
| Mönchengladbach, Germany, 41063 | |
| Active, not recruiting | |
| München, Germany, 81675 | |
| Terminated | |
| Münster, Germany, 48149 | |
| Active, not recruiting | |
| Münster, Germany, 48149 | |
| Active, not recruiting | |
| Neunkirchen/saar, Germany, 66538 | |
| Not yet recruiting | |
| Northeim, Germany, 37154 | |
| Not yet recruiting | |
| Oldenburg, Germany, 26121 | |
| Active, not recruiting | |
| Paderborn, Germany, 33098 | |
| Active, not recruiting | |
| Recklinghausen, Germany, 45659 | |
| Recruiting | |
| Regensburg, Germany, 93049 | |
| Recruiting | |
| Saarbruecken, Germany, 66113 | |
| Not yet recruiting | |
| Stade, Germany, 21680 | |
| Terminated | |
| Stuttgart, Germany, 70176 | |
| Not yet recruiting | |
| Trier, Germany, 54292 | |
| Active, not recruiting | |
| Tübingen, Germany, 72076 | |
| Active, not recruiting | |
| ULM, Germany, 89081 | |
| Active, not recruiting | |
| Wiesbaden, Germany, 65199 | |
| Active, not recruiting | |
| Würzburg, Germany, 97070 | |
| Hungary | |
| Active, not recruiting | |
| Budapest, Hungary, 1083 | |
| Recruiting | |
| Budapest, Hungary, 1122 | |
| Active, not recruiting | |
| Debrecen, Hungary, 4004 | |
| Not yet recruiting | |
| Gyor, Hungary, 9024 | |
| Not yet recruiting | |
| Kaposvar, Hungary, 7400 | |
| Not yet recruiting | |
| Pecs, Hungary, 7624 | |
| Recruiting | |
| Szeged, Hungary, 6720 | |
| Israel | |
| Not yet recruiting | |
| Haifa, Israel, 31096 | |
| Not yet recruiting | |
| Jerusalem, Israel, 91120 | |
| Not yet recruiting | |
| Petach Tikva, Israel, 49100 | |
| Not yet recruiting | |
| Ramat Gan, Israel, 52662 | |
| Italy | |
| Active, not recruiting | |
| Bergamo, Italy, 24127 | |
| Not yet recruiting | |
| Milano, Italy, 20122 | |
| Active, not recruiting | |
| Milano, Italy, 20162 | |
| Active, not recruiting | |
| Modena, Italy, 41100 | |
| Recruiting | |
| Padova, Italy, 35128 | |
| Active, not recruiting | |
| Roma, Italy, 00152 | |
| Active, not recruiting | |
| Rozzano, Italy, 20089 | |
| Japan | |
| Active, not recruiting | |
| Aichi, Japan, 466-8650 | |
| Active, not recruiting | |
| Aichi, Japan, 464-8681 | |
| Recruiting | |
| Aichi, Japan, 467-8602 | |
| Recruiting | |
| Aomori, Japan, 030-8553 | |
| Recruiting | |
| Chiba, Japan, 260-8717 | |
| Recruiting | |
| Chiba, Japan, 277-8577 | |
| Active, not recruiting | |
| Ehime, Japan, 791-0280 | |
| Active, not recruiting | |
| Fukuoka, Japan, 811-1395 | |
| Recruiting | |
| Gunma, Japan, 371-8511 | |
| Recruiting | |
| Hiroshima, Japan, 734-8551 | |
| Recruiting | |
| Hyogo, Japan, 673-8558 | |
| Active, not recruiting | |
| Hyogo, Japan, 650-0047 | |
| Active, not recruiting | |
| Kanagawa, Japan, 259-1193 | |
| Recruiting | |
| Kumamoto, Japan, 860-8556 | |
| Active, not recruiting | |
| Kyoto, Japan, 602-8566 | |
| Active, not recruiting | |
| Miyagi, Japan, 980-8574 | |
| Recruiting | |
| Nagano, Japan, 390-8621 | |
| Active, not recruiting | |
| Niigata, Japan, 951-8566 | |
| Active, not recruiting | |
| Osaka, Japan, 570-8540 | |
| Active, not recruiting | |
| Tochigi, Japan, 329-0498 | |
| Recruiting | |
| Tokyo, Japan, 105-8470 | |
| Active, not recruiting | |
| Tokyo, Japan, 135-8550 | |
| Recruiting | |
| Tokyo, Japan, 201-8601 | |
| Active, not recruiting | |
| Tokyo, Japan, 104-0045 | |
| Russian Federation | |
| Not yet recruiting | |
| Moscow, Russian Federation, 115478 | |
| Recruiting | |
| Nizhny Novgorod, Russian Federation, 603126 | |
| Recruiting | |
| Petrozavodsk, Russian Federation, 185019 | |
| Spain | |
| Active, not recruiting | |
| Alcorcon, Spain, 28922 | |
| Active, not recruiting | |
| Badalona, Spain, 08915 | |
| Active, not recruiting | |
| Bilbao, Spain, 48013 | |
| Active, not recruiting | |
| Madrid, Spain, 28046 | |
| Not yet recruiting | |
| Madrid, Spain, 28007 | |
| Active, not recruiting | |
| Madrid, Spain, 28041 | |
| Active, not recruiting | |
| Sabadell, Spain, 08208 | |
| Sweden | |
| Recruiting | |
| Göteborg, Sweden, S-413 45 | |
| Terminated | |
| Stockholm, Sweden, 11883 | |
| Taiwan | |
| Recruiting | |
| Taipei, Taiwan, 100 | |
| Not yet recruiting | |
| Taipei, Taiwan, 112 | |
| Recruiting | |
| Taoyuan, Taiwan, 333 | |
| United Kingdom | |
| Recruiting | |
| Aberdeen, United Kingdom, AB9 2ZB | |
| Active, not recruiting | |
| Birmingham, United Kingdom, B15 2TH | |
| Active, not recruiting | |
| Bournemouth, United Kingdom, BH7 7DW | |
| Recruiting | |
| Bristol, United Kingdom, BS2 8ED | |
| Active, not recruiting | |
| Cambridge, United Kingdom, CB2 2QQ | |
| Active, not recruiting | |
| Canterbury, United Kingdom, CT1 3NG | |
| Active, not recruiting | |
| Cardiff, United Kingdom, CF14 2TL | |
| Recruiting | |
| Cottingham, United Kingdom, HU16 5JG | |
| Recruiting | |
| Edinburgh, United Kingdom, EH4 2XU | |
| Recruiting | |
| Glasgow, United Kingdom, G12 0YN | |
| Active, not recruiting | |
| Great Yarmouth, United Kingdom, NR31 6LA | |
| Recruiting | |
| Harlow, United Kingdom, CM20 1QX | |
| Recruiting | |
| Leeds, United Kingdom, LS9 7TF | |
| Recruiting | |
| Leicester, United Kingdom, LE1 5WW | |
| Active, not recruiting | |
| London, United Kingdom, SW17 0QT | |
| Recruiting | |
| London, United Kingdom, W12 OHS | |
| Recruiting | |
| London, United Kingdom, SE5 9RS | |
| Active, not recruiting | |
| London, United Kingdom, EC1M 6BQ | |
| Recruiting | |
| London, United Kingdom, NW3 2QG | |
| Active, not recruiting | |
| Manchester, United Kingdom, M20 4BX | |
| Recruiting | |
| Norwich, United Kingdom, NR4 7UY | |
| Active, not recruiting | |
| Nottingham, United Kingdom, NG5 1PB | |
| Active, not recruiting | |
| Oxford, United Kingdom, OX3 7LJ | |
| Active, not recruiting | |
| Portsmouth, United Kingdom, PO6 3LY | |
| Active, not recruiting | |
| Southampton, United Kingdom, SO16 6YD | |
| Active, not recruiting | |
| Sutton, United Kingdom, SM2 5PT | |
| Recruiting | |
| Swansea, United Kingdom, SA2 8QA | |
| Recruiting | |
| Swindon, United Kingdom, SN3 6BB | |
| Recruiting | |
| Truro, United Kingdom, TR1 3LJ | |
Sponsors and Collaborators
Hoffmann-La Roche
German Low Grade Lymphoma Study Group
Institute of Cancer Research, United Kingdom
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01332968 History of Changes |
| Other Study ID Numbers: | BO21223 |
| Study First Received: | April 8, 2011 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013