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

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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