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A Phase III, Open-Label, Multicenter, Single-Arm, Retreatment Study of Galiximab in Combination With Rituximab for Subjects With Relapsed, Follicular Non-Hodgkin's Lymphoma Who Previously Responded on Study 114-NH-301


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin Lymphoma

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Trial Information

A Phase III, Open-Label, Multicenter, Single-Arm, Retreatment Study of Galiximab in Combination With Rituximab for Subjects With Relapsed, Follicular Non-Hodgkin's Lymphoma Who Previously Responded on Study 114-NH-301


Key

Inclusion Criteria:



- Demonstrated a response (CR, CRu, or PR) on Study 114-NH-301 (Galiximab in
combination with Rituximab compared with Rituximab in combination with Placebo) and
then relapsed or progressed with a TTP >=6 months. Relapsed disease is defined as
documented disease progression using the International Workshop Response Criteria
(IWRC).

- Bidimensionally measurable disease with at least 1 lesion >=2.0 cm in a single
dimension.

- Acceptable hematologic, hepatic, and renal function.

Key Exclusion Criteria:

- Any lymphoma therapy between Final Visit on Study 114-NH-301 and Study Day 1 of this
retreatment study.

- Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders
within 3 weeks prior to Study Day 1.

- Transfusion-dependent subjects.

- Presence of central nervous system (CNS) lymphoma.

- Histologic transformation.

- Presence of pleural or peritoneal effusion with positive cytology for lymphoma.

- Another primary malignancy requiring active treatment.

- Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active
uncontrolled bacterial, viral, or fungal infections; or other conditions that would
compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.

- New York Heart Association Class III or IV cardiac disease or myocardial infarction
within 6 months prior to Study Day 1.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety measures include: adverse event rates, clinical laboratory results, development of anti-galiximab and human anti-chimeric antibodies

Outcome Time Frame:

Study period is approx. 2 years

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

114-NH-302

NCT ID:

NCT00384150

Start Date:

November 2007

Completion Date:

March 2010

Related Keywords:

  • Non-Hodgkin Lymphoma
  • galiximab
  • antibody
  • refractory
  • follicular
  • relapsed
  • NHL
  • rituximab
  • retreatment
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

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