Phase II Study of Ofatumumab Plus ICE or DHAP Chemotherapy Regimen in Relapsed/ Refractory DLBCL
Status: | Archived |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | May 2009 |
End Date: | December 2011 |
A Single Arm, Safety and Efficacy Study of Ofatumumab in Combination With ICE or DHAP Chemotherapy in Relapsed or Refractory Aggressive Lymphoma Prior to Autologous Stem Cell Transplantation
The purpose of this study is to evaluate the safety and efficacy of ofatumumab used in
combination with ICE or DHAP salvage chemotherapy regimens in subjects with relapsed or
refractory DLBCL who are eligible for autologous stem cell transplant.
Rituximab combined with anthracycline based chemotherapy is the most common first-line
treatment for subjects with diffuse large B cell lymphoma (DLBCL). Subjects requiring
second-line therapy will most often receive rituximab in combination with salvage
chemotherapy as an induction therapy prior to autologous stem cell transplant. With
rituximab being in first-line therapy, the response rates for subjects receiving rituximab
plus salvage chemotherapy has significantly decreased. Treatment with ofatumumab may be
able to overcome the resistance to rituximab in the second-line setting and offer improved
response rates. The objective of this study is to evaluate the overall response rate of
ofatumumab in combination with ICE or DHAP chemotherapy prior to autologous stem cell
transplant. Additional objectives are to evaluate the complete response rate, ability to
mobilize CD34+ cells, progression-free survival (PFS) and overall survival.
We found this trial at
7
sites
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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1 Medical Center Drive
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
304-598-4800
West Virginia University Hospitals Inc. WVU Healthcare is two corporations, University Health Associates and WVU...
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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