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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 4, 2006
First Posted Date  ICMJE October 5, 2006
Last Update Posted Date November 26, 2015
Study Start Date  ICMJE November 2007
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2006)
Safety
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • Pharmacokinetics [ Time Frame: Study period is approx. 2 years ]
  • To further characterize the efficacy profile of galiximab in combination with rituximab [ Time Frame: Study period is approx. 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2006)
  • Pharmacokinetics
  • Efficacy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, Non-Hodgkin's
Intervention  ICMJE Drug: galiximab in combination with rituximab
galiximab (500 mg/m2 IV) in combination with rituximab (375 mg/m2 IV)once weekly for 4 weeks.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 11, 2009)
16
Original Enrollment  ICMJE
 (submitted: October 4, 2006)
345
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Austria,   Belarus,   Canada,   Croatia,   Czech Republic,   France,   Germany,   Israel,   Italy,   Latvia,   Lithuania,   Moldova, Republic of,   New Zealand,   Norway,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT00384150
Other Study ID Numbers  ICMJE 114-NH-302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP