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

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ClinicalTrials.gov Identifier: NCT00384150
Recruitment Status : Terminated (Enrollment challenges due to changes in standards of care resulted in premature termination. No safety or efficacy events factored into this action.)
First Posted : October 5, 2006
Last Update Posted : November 26, 2015
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin's Drug: galiximab in combination with rituximab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Intervention Details:
  • Drug: galiximab in combination with rituximab
    galiximab (500 mg/m2 IV) in combination with rituximab (375 mg/m2 IV)once weekly for 4 weeks.

Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: Study period is approx. 2 years ]
  2. To further characterize the efficacy profile of galiximab in combination with rituximab [ Time Frame: Study period is approx. 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384150


Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00384150    
Other Study ID Numbers: 114-NH-302
First Posted: October 5, 2006    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: October 2015
Keywords provided by Biogen:
galiximab
antibody
refractory
follicular
 relapsed
NHL
rituximab
retreatment
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Galiximab
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents