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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 (GADOLIN)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01059630
First received: January 28, 2010
Last updated: April 1, 2015
Last verified: April 2015
  Purpose

This open-label, multicenter, randomized, Phase III study will investigate the efficacy and safety of RO5072759 (GA101) combined with bendamustine compared with bendamustine alone in patients with rituximab-refractory, indolent Non-Hodgkin's lymphoma (NHL). Patients will be randomized to receive a maximum of 6 cycles of GA101 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2 - 6) and then every 2 months until disease progression for up to 2 years plus bendamustine (90 mg/m2 IV, on days 2 and 3 of cycle 1 and days 1 and 2 of cycles 2 - 6) on 28 day cycles or a maximum of 6 cycles of bendamustine alone (120 mg/m2 IV, on days 1 and 2 of cycles 1 - 6) on 28 day cycles.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: RO5072759
Drug: bendamustine
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: An Open-Label, Multicenter, Randomized, Phase III Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Time from randomization to first occurrence of progression or relapse, or death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Time from randomization to death ] [ Designated as safety issue: No ]
  • Complete response (CR) and overall response (CR or partial response [PR]) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Best response [ Time Frame: Up to 12 months after start of treatment ] [ Designated as safety issue: No ]

Enrollment: 414
Study Start Date: April 2010
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A Drug: bendamustine
Intravenous repeating dose
Experimental: Arm B Drug: RO5072759
Intravenous repeating dose
Drug: bendamustine
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

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 study treatment). Patients with prior bendamustine treatment (greater than 2 years prior to the start of study treatment ) are eligible if they meet both of the following criteria: achieved either partial or complete response to the bendamustine regimen of at least 12 months in duration prior to relapse/progression and experienced progression following a regimen containing an alkylating agent
  • 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 or histological evidence of transformation to high grade or diffuse large B-cell lymphoma
  • History of other malignancy that could affect compliance with the protocol or interpretation of results
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059630

  Hide Study Locations
Locations
United States, Alabama
Mobile, Alabama, United States, 36608
United States, Arizona
Casa Grande, Arizona, United States, 85122
United States, Arkansas
Rogers, Arkansas, United States, 72758
United States, California
Bellflower, California, United States, 90706
Pleasant Hill, California, United States, 94523
San Diego, California, United States, 92123
United States, District of Columbia
Washington, District of Columbia, United States, 20057
Washington, District of Columbia, United States, 20422
United States, Florida
Gainesville, Florida, United States, 32610
Gainesville, Florida, United States, 33610-0277
Orlando, Florida, United States, 32806
United States, Illinois
Chicago, Illinois, United States, 60612
Quincy, Illinois, United States, 62301
Springfield, Illinois, United States, 62794-9677
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Maine
Scarborough, Maine, United States, 04074
United States, Maryland
Hagerstown, Maryland, United States, 21740
United States, Missouri
Jefferson City, Missouri, United States, 65101
United States, New Jersey
Hackensack, New Jersey, United States, 07601
Mount Holly, New Jersey, United States, 08060
United States, New Mexico
Farmington, New Mexico, United States, 87401
United States, Ohio
Columbus, Ohio, United States, 43219
United States, Oregon
Portland, Oregon, United States, 97239
Portland, Oregon, United States, 97210
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
Pittsburgh, Pennsylvania, United States, 15224
United States, South Dakota
Sioux Falls, South Dakota, United States, 57105
United States, Texas
Corpus Christi, Texas, United States, 78405
Houston, Texas, United States, 77030
United States, Washington
Seattle, Washington, United States, 98109
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Austria
Graz, Austria, 8036
Salzburg, Austria, 5020
Wien, Austria, 1090
Belgium
Antwerpen, Belgium, 2060
Kortrijk, Belgium, 8500
Mons, Belgium, 7000
Canada, Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y 5L3
Vancouver, British Columbia, Canada, V5Z 1H6
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3E0V9
Canada, New Brunswick
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
East York, Ontario, Canada, M4C 3E7
Toronto, Ontario, Canada, M4X 1K9
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Montreal, Quebec, Canada, H2L4M1
Canada, Saskatchewan
Regina, Saskatchewan, Canada, S4T 7T1
Canada
Quebec, Canada, G1J 1Z4
Czech Republic
Brno, Czech Republic, 625 00
Hradec Kralove, Czech Republic, 500 05
Prague, Czech Republic, 12802
France
Bordeaux, France, 33300
Bordeaux, France, 33076
Creteil, France, 94010
Dijon, France, 21079
LeMans, France, 72015
Lille, France, 59037
Lyon, France, 69008
Metz, France, 57038
Montpellier, France, 34295
Nantes, France, 44093
Paris, France, 75475
Paris, France, 75743
Pessac, France, 33604
Pierre Benite, France, 69495
Poitiers, France, 86021
Reims, France, 51100
Rennes, France, 35033
Rouen, France, 76038
Strasbourg, France, 67000
Vandoeuvre, France, 54511
Germany
Duisburg, Germany, 47166
Frankfurt am Main, Germany, 65929
Hamburg, Germany, 20099
Leipzig, Germany, 04103
Muenchen, Germany, 81377
Villingen-Schwenningen, Germany, 78052
Italy
Modena, Emilia-Romagna, Italy, 41100
Udine, Friuli-Venezia Giulia, Italy, 33100
Roma, Lazio, Italy, 00133
Roma, Lazio, Italy, 00161
Milano, Lombardia, Italy, 20133
Pavia, Lombardia, Italy, 27100
Torino, Piemonte, Italy, 10128
Torino, Piemonte, Italy, 10126
Bari, Puglia, Italy, 70124
Lecce, Puglia, Italy, 73100
Catania, Sicilia, Italy, 95124
Firenze, Toscana, Italy, 50141
Netherlands
Amsterdam, Netherlands, 1081 HV
Den Haag, Netherlands, 2504 LN
Dordrecht, Netherlands, 3371 NM
Groningen, Netherlands, 9700 RB
Rotterdam, Netherlands, 3075 EA
Rotterdam, Netherlands, 3000 CA
Russian Federation
Irkutsk, Russian Federation, 664035
Moscow, Russian Federation, 125167
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 125101
Petrozavodsk, Russian Federation, 185019
Ryazan, Russian Federation, 390039
Saint-Petersburg, Russian Federation, 197022
St. Petersburg, Russian Federation, 191024
Spain
Pamplona, Navarra, Spain, 31008
Sevillac, Sevilla, Spain, 41014
Madrid, Spain, 28006
Madrid, Spain, 28046
Vizcaya, Spain, 48013
Zaragoza, Spain, 50009
Sweden
Lund, Sweden, 22185
Stockholm, Sweden, 14186
Umea, Sweden, 90185
Uppsala, Sweden, 75185
Switzerland
Basel, Switzerland, 4031
Bern, Switzerland, 3010
Chur, Switzerland, 7000
United Kingdom
Glasgow, United Kingdom, G12 0YN
Leicester, United Kingdom, LE1 5WW
London, United Kingdom, EC1M 6BQ
Newcastle upon Tyne, United Kingdom, NE7 7DN
Swansea, United Kingdom, SA2 8QA
Sponsors and Collaborators
Genentech, Inc.
Roche Pharma AG
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01059630     History of Changes
Other Study ID Numbers: GAO4753g, GO01297
Study First Received: January 28, 2010
Last Updated: April 1, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
follicular
follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bendamustine
Obinutuzumab
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2015