Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma
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|ClinicalTrials.gov Identifier: NCT01768338|
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : August 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma||Drug: Ofatumumab combined with SB-485232||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Recombinant Human Interleukin-18 (SB-485232) in Combination With Ofatumumab After Autologous Peripheral Blood Stem Cell Transplantation for Lymphoma|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||August 3, 2017|
Experimental: Ofatumumab combined with SB-485232
Otatumumab: 1000 mg IV for 4 weeks. SB-485232: escalating doses (3 ug/kg up to 30 ug/kg) for 8 weeks.
Drug: Ofatumumab combined with SB-485232
Ofatumumab with escalating doses of SB-485232
- To evaluate the the number of subjects with adverse events who receive SB-485232 when given in combination with ofatumumab [ Time Frame: 8 weeks ]Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 which uses a scale of 1 (mild) to 5 (caused death).
- To evaluate the biologic effects of SB-485232 given in combination with ofatumumab [ Time Frame: 8 weeks ]Biologic effects will be assessed by flow cytometric analysis of PBMCs and ELISA tests to measure plasma cytokines and chemokines.
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): NCT01768338
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Michael Robertson, MD||Indiana University Melvin and Bren Simon Cancer Center|