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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, Inc.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01059630
First received: January 28, 2010
Last updated: August 4, 2014
Last verified: August 2014

January 28, 2010
August 4, 2014
April 2010
August 2014   (final data collection date for primary outcome measure)
Progression-free survival (PFS) [ Time Frame: Time from randomization to first occurrence of progression or relapse, or death ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01059630 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
  • Drug: bendamustine
    Intravenous repeating dose
  • Drug: RO5072759
    Intravenous repeating dose
  • Active Comparator: Arm A
    Intervention: Drug: bendamustine
  • Experimental: Arm B
    Interventions:
    • Drug: bendamustine
    • Drug: RO5072759
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
410
July 2018
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Reference Study ID Number: GAO4753g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Austria,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Italy,   Netherlands,   Russian Federation,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT01059630
GAO4753g, GO01297
Not Provided
Genentech, Inc.
Genentech, Inc.
Roche Pharma AG
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP