Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients
NCT ID: NCT00494780
Last Updated: 2014-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2007-06-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Active Comparator 1
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
Ofatumumab
ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free 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
Cyclophosphamide
Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
Doxorubicin
Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start
Vincristine
Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
Prednisolone, Prednisone or equivalent
100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start
Active Comparator 2
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
Ofatumumab
ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free 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
Cyclophosphamide
Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
Doxorubicin
Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start
Vincristine
Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
Prednisolone, Prednisone or equivalent
100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start
Interventions
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Ofatumumab
ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free 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
Cyclophosphamide
Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
Doxorubicin
Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start
Vincristine
Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start
Prednisolone, Prednisone or equivalent
100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of Follicular lymphoma
* 18 years or above
* Verbal and written information about the study
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Buffalo, New York, United States
Countries
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References
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Czuczman MS, Hess G, Gadeberg OV, Pedersen LM, Goldstein N, Gupta I, Jewell RC, Lin TS, Lisby S, Strange C, Windfeld K, Viardot A; 409 Study Investigators. Chemoimmunotherapy with ofatumumab in combination with CHOP in previously untreated follicular lymphoma. Br J Haematol. 2012 May;157(4):438-45. doi: 10.1111/j.1365-2141.2012.09086.x. Epub 2012 Mar 13.
Other Identifiers
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Hx-CD20-409
Identifier Type: OTHER
Identifier Source: secondary_id
The MUNIN trial
Identifier Type: -
Identifier Source: secondary_id
111775
Identifier Type: -
Identifier Source: org_study_id
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