Galiximab in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00516217|
Recruitment Status : Completed
First Posted : August 15, 2007
Results First Posted : February 4, 2015
Last Update Posted : July 6, 2016
RATIONALE: Monoclonal antibodies, such as galiximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
PURPOSE: This phase II trial is studying how well galiximab works in treating patients with relapsed or refractory Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: galiximab||Phase 2|
- To determine the response rate (complete and overall response) in patients with relapsed or refractory Hodgkin lymphoma (HL) treated with galiximab.
- To assess the duration of response, progression-free survival, and overall survival of patients with relapsed or refractory HL.
- To assess the safety and tolerability of galiximab in patients with relapsed or refractory HL.
- To determine if FDG-PET correlates with outcome in patients with relapsed or refractory HL treated with galiximab.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive galiximab IV over 60 minutes on days 1, 8, 15, and 22 in month 1.
- Extended induction therapy: Patients receive galiximab IV over 60 minutes once every four weeks in the absence of disease progression or unacceptable toxicity.
Patients also undergo FDG-PET/CT imaging at baseline and at time of first restaging (within 7 days prior to week 8 treatment).
After completion of study treatment, patients are followed periodically for 10 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Galiximab (Anti-CD80) for Patients With Relapsed/Refractory Hodgkin Lymphoma|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||February 2015|
Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
- Overall Response [ Time Frame: Duration of treatment (up to 10 years) ]
Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma.
CR: complete disappearance of all detectable disease PR: >=50% decrease in the sum of the product of diameters of indicator lesions.
- 12 Month Overall Survival Rate [ Time Frame: 12 months ]Percentage of patients who were alive at 12 months. The 12-month survival rate was estimated using the Kaplan Meier method.
- 6 Month Progression Free Survival Rate [ Time Frame: 6 months ]
Percentage of patients who were progression free at 6 months. The 6-month progression free rate was estimated using the Kaplan Meier method.
Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a appearance of any new lesion > 1.5 cm, at least 50% increase from nadir in the sum of products of involved nodes, or a 50% increase in the longest diameter of any single node.
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): NCT00516217
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|Study Chair:||Sonali Smith, MD||University of Chicago|