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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 currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Genentech
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01059630
First received: January 28, 2010
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This open-label, multicenter, randomized, Phase III study will investigate the e fficacy 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 o f 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: bendamustine
Drug: RO5072759
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:

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 ]

Estimated Enrollment: 410
Study Start Date: April 2010
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: August 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: bendamustine
Intravenous repeating dose
Drug: RO5072759
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

Contacts
Contact: Reference Study ID Number: GAO4753g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, Alabama
Completed
Mobile, Alabama, United States, 36608
United States, Arizona
Completed
Casa Grande, Arizona, United States, 85122
United States, Arkansas
Recruiting
Rogers, Arkansas, United States, 72758
United States, California
Recruiting
Bellflower, California, United States, 90706
Completed
Pleasant Hill, California, United States, 94523
Recruiting
San Diego, California, United States, 92123
United States, District of Columbia
Completed
Washington, District of Columbia, United States, 20422
Recruiting
Washington, District of Columbia, United States, 20057
United States, Florida
Completed
Gainesville, Florida, United States, 32610
Completed
Gainesville, Florida, United States, 33610-0277
Completed
Orlando, Florida, United States, 32806
United States, Illinois
Completed
Chicago, Illinois, United States, 60612
Completed
Quincy, Illinois, United States, 62301
Active, not recruiting
Springfield, Illinois, United States, 62794-9677
United States, Iowa
Recruiting
Iowa City, Iowa, United States, 52242
United States, Kentucky
Recruiting
Louisville, Kentucky, United States, 40202
United States, Maine
Recruiting
Scarborough, Maine, United States, 04074
United States, Maryland
Completed
Hagerstown, Maryland, United States, 21740
United States, Missouri
Recruiting
Jefferson City, Missouri, United States, 65101
United States, New Jersey
Recruiting
Hackensack, New Jersey, United States, 07601
Completed
Mount Holly, New Jersey, United States, 08060
United States, New Mexico
Recruiting
Farmington, New Mexico, United States, 87401
United States, Ohio
Recruiting
Columbus, Ohio, United States, 43219
Recruiting
Stockholm, Ohio, United States, 14186
United States, Oregon
Completed
Portland, Oregon, United States, 97210
Completed
Portland, Oregon, United States, 97239
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19107
Completed
Pittsburgh, Pennsylvania, United States, 15224
United States, South Dakota
Completed
Sioux Falls, South Dakota, United States, 57105
United States, Texas
Completed
Corpus Christi, Texas, United States, 78405
Recruiting
Houston, Texas, United States, 77030
United States, Washington
Recruiting
Seattle, Washington, United States, 98109
United States, Wisconsin
Recruiting
Madison, Wisconsin, United States, 53792
Austria
Recruiting
Graz, Austria, 8036
Completed
Salzburg, Austria, 5020
Recruiting
Wien, Austria, 1090
Belgium
Recruiting
Antwerpen, Belgium, 2060
Recruiting
Kortrijk, Belgium, 8500
Completed
Mons, Belgium, 7000
Canada, Alberta
Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Recruiting
Vancouver, British Columbia, Canada, V5Z 1H6
Canada, Manitoba
Recruiting
Winnipeg, Manitoba, Canada, R3E0V9
Canada, New Brunswick
Recruiting
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
Recruiting
East York, Ontario, Canada, M4C 3E7
Recruiting
Toronto, Ontario, Canada, M4X 1K9
Canada, Quebec
Recruiting
Montreal, Quebec, Canada, H3T 1E2
Recruiting
Montreal, Quebec, Canada, H2L4M1
Canada, Saskatchewan
Active, not recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Canada
Recruiting
Quebec, Canada, G1J 1Z4
Czech Republic
Recruiting
Brno, Czech Republic, 625 00
Recruiting
Hradec Kralove, Czech Republic, 500 05
Recruiting
Prague, Czech Republic, 12802
France
Recruiting
Bordeaux, France, 33300
Recruiting
Bordeaux, France, 33076
Recruiting
Creteil, France, 94010
Recruiting
Dijon, France, 21079
Recruiting
LeMans, France, 72015
Recruiting
Lille, France, 59037
Recruiting
Lyon, France, 69008
Recruiting
Metz, France, 57038
Recruiting
Montpellier, France, 34295
Recruiting
Nantes, France, 44093
Completed
Paris, France, 75743
Recruiting
Paris, France, 75475
Recruiting
Pessac, France, 33604
Recruiting
Pierre Benite, France, 69495
Recruiting
Poitiers, France, 86021
Completed
Reims, France, 51100
Recruiting
Rennes, France, 35033
Recruiting
Rouen, France, 76038
Recruiting
Strasbourg, France, 67000
Recruiting
Vandoeuvre, France, 54511
Germany
Completed
Duisburg, Germany, 47166
Recruiting
Frankfurt Am Main, Germany, 65929
Completed
Hamburg, Germany, 20099
Completed
Leipzig, Germany, 04103
Recruiting
Muenchen, Germany, 81377
Recruiting
Villingen-Schwenningen, Germany, 78052
Italy
Recruiting
Modena, Emilia-Romagna, Italy, 41100
Recruiting
Udine, Friuli-Venezia Giulia, Italy, 33100
Completed
Roma, Lazio, Italy, 00133
Recruiting
Roma, Lazio, Italy, 00161
Completed
Milano, Lombardia, Italy, 20133
Recruiting
Pavia, Lombardia, Italy, 27100
Recruiting
Torino, Piemonte, Italy, 10126
Recruiting
Torino, Piemonte, Italy, 10128
Terminated
Bari, Puglia, Italy, 70124
Recruiting
Lecce, Puglia, Italy, 73100
Active, not recruiting
Catania, Sicilia, Italy, 95124
Active, not recruiting
Firenze, Toscana, Italy, 50141
Netherlands
Recruiting
Amsterdam, Netherlands, 1081 HV
Completed
Den Haag, Netherlands, 2545 CH
Completed
Dordrecht, Netherlands, 3371 NM
Completed
Groningen, Netherlands, 9713 GZ
Recruiting
Rotterdam, Netherlands, 3015 GD
Recruiting
Rotterdam, Netherlands, 3075 EA
Russian Federation
Recruiting
Irkutsk, Russian Federation, 664035
Recruiting
Moscow, Russian Federation, 125167
Recruiting
Moscow, Russian Federation, 115478
Completed
Moscow, Russian Federation, 125101
Recruiting
Petrozavodsk, Russian Federation, 185019
Completed
Ryazan, Russian Federation, 390039
Active, not recruiting
Saint-Petersburg, Russian Federation, 197022
Recruiting
St. Petersburg, Russian Federation, 191024
Spain
Completed
Pamplona, Navarra, Spain, 31008
Recruiting
Sevillac, Sevilla, Spain, 41014
Recruiting
Madrid, Spain, 28006
Completed
Madrid, Spain, 28046
Recruiting
Vizcaya, Spain, 48013
Active, not recruiting
Zaragoza, Spain, 50009
Sweden
Recruiting
Lund, Sweden, 22185
Recruiting
Umea, Sweden, 90185
Recruiting
Uppsala, Sweden, 75185
Switzerland
Recruiting
Basel, Switzerland, 4031
Completed
Bern, Switzerland, 3010
Completed
Chur, Switzerland, 7000
United Kingdom
Recruiting
Glasgow, United Kingdom, G12 0YN
Recruiting
Leicester, United Kingdom, LE1 5WW
Recruiting
London, United Kingdom, EC1M 6BQ
Recruiting
Newcastle upon Tyne, United Kingdom, NE7 7DN
Recruiting
Swansea, United Kingdom, SA2 8QA
Sponsors and Collaborators
Genentech
Roche Pharma AG
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01059630     History of Changes
Other Study ID Numbers: GAO4753g, GO01297
Study First Received: January 28, 2010
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
follicular
follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Nitrogen Mustard Compounds
Rituximab
Obinutuzumab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 19, 2014