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An Open-label, Multi-center, Randomized Study to Evaluate the Efficacy on Tumor Response of GA101 (RO5072759) Monotherapy Versus Rituximab Monotherapy in Patients With Relapsed CD20+ Indolent Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

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Trial Information

An Open-label, Multi-center, Randomized Study to Evaluate the Efficacy on Tumor Response of GA101 (RO5072759) Monotherapy Versus Rituximab Monotherapy in Patients With Relapsed CD20+ Indolent Non-Hodgkin's Lymphoma


Inclusion Criteria:



- adult patients, >=18 years of age

- relapsed CD20+ indolent B-cell non-Hodgkin's lymphoma

- documented history of response of >/= 6 months duration from last
rituximab-containing regimen

- clinical indication for treatment as determined by the investigator

- ECOG performance status 0-2

Exclusion Criteria:

- prior use of any investigational monoclonal antibody within 6 months of study start

- prior use of any anti-cancer vaccine

- prior use of rituximab within 8 weeks of study entry

- radioimmunotherapy within 3 months prior to study entry

- CNS lymphoma or evidence of transformation to high-grade or diffuse large B-cell
lymphoma

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase 2: Overall response rate

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Canada: Health Canada

Study ID:

BO21003

NCT ID:

NCT00576758

Start Date:

January 2008

Completion Date:

March 2013

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Albany, Georgia  31701
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Austin, Texas  78705
Seattle, Washington  98195
Hackensack, New Jersey  07601
Denver, Colorado  
Baltimore, Maryland  21287
Charlotte, North Carolina