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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

  Show 122 Study Locations
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