Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL)

Sponsor
Biogen
Study ID
NCT00384150
Phase
PHASE3
Status
Terminated

Conditions

  • Lymphoma, Non-Hodgkin's

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a Phase III, multicenter, global, open-label, single-arm, retreatment study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with relapsed or refractory, follicular NHL who demonstrated a response on Study 114-NH-301 with a time-to-progression \>=6 months.

Key Dates

First listed
Oct 5, 2006
Start date
Nov 30, 2007
Status verified
Oct 2015
Primary completion
Jan 31, 2010
Completion
Jan 31, 2010

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies [ Time Frame: Study period is approx. 2 years ]

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