Ofatumumab (Humax-CD20) With CHOP in FL Patients - Full Text View

Purpose

To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP in previously untreated patients with Follicular Lymphoma

Condition	Intervention	Phase
Follicular Lymphoma	Drug: Ofatumumab	Phase II

MedlinePlus related topics:

Cancer Lymphoma

Drug Information available for:

Tositumomab Sodium chloride Ofatumumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title:	An Open-Labeled, Randomized, Two-Dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With CHOP, in Patients With Previously Untreated Follicular Lymphoma.

Further study details as provided by Genmab:

Primary Outcome Measures:

Objective Response Rate as measured from start of treatment until 3 months after last infusion assessed according to the standardized response criteria for non-Hodgkin's Lymphomas (1;2) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of response, Time to next FL- therapy, Reduction in tumor size, Adverse Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	56
Study Start Date:	May 2007
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 500mg	Drug: Ofatumumab ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogenefree saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given.
2: Active Comparator Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 1000mg	Drug: Ofatumumab ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogenefree saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

No previous treatment for Follicular Lymphoma
Clinical suspicion that the Follicular Lymphoma has transformed to aggressive lymphoma
Several diseases such as malignancies etc.
Screening laboratory values
Current participation in any other interventional clinical study
Breast feeding women or pregnant women
Women of childbearing potential not willing to use adequate contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494780

Locations


United States, Illinois
	Rush University Medical Center
	Chicago, Illinois, United States, 60612

United States, New York
	Roswell Park Cancer Institute
	Buffalo, New York, United States, 14263

United States, Ohio
	Cleveland Clinic
	Cleveland, Ohio, United States, 44195

Czech Republic
	University Hospital Motol
	Prague, Czech Republic
	University Hospital Hradec Kralove
	Hradec Kralove, Czech Republic, 50005
	General Faculty Hospital, Charles University Prague
	Prague, Czech Republic, 128 08
	University Hospital Bmo
	Bmo, Czech Republic, 625 00
	Nemocnice Ceske Budejovice
	Budejovice, Czech Republic, 370 87

Denmark
	Vejle Hospital
	Vejle, Denmark, 7100
	Odense Universitets Hospital
	Odense, Denmark, 5000

Germany
	Universitätsklinikum Ulm
	Ulm, Germany, 89081
	Universitätsklinikum Essen
	Essen, Germany, 45122
	Universitätsklinikum Göttingen
	Göttingen, Germany, 37075
	Johannes Gutenberg University
	Mainz, Germany, 55101

Sweden
	University Hospital in Lund
	Lund, Sweden, 221 85

Sponsors and Collaborators

Genmab

GlaxoSmithKline

Investigators


Principal Investigator:	Myron Czuczman, Ass. Prof. M.D.	Roswell Park Cancer Institute

More Information

Responsible Party:	Genmab A/S ( Genmab A/S )
Study ID Numbers:	Hx-CD20-409
First Received:	June 29, 2007
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00494780
Health Authority:	United States: Food and Drug Administration; Germany: Paul-Ehrlich-Institut; Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Czech Republic: State Institute for Drug Control