Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma - Tabular View

Tracking Information
First Received Date ^ICMJE	September 22, 2004
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00092274 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma
Official Title ^ICMJE	An Open-Label, International, Multicenter, Dose Escalating, Phase I/II Study of HuMax-CD20 in Patients With Relapsed or Refractory Follicular Lymphoma Grade I-II
Brief Summary	The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).
Detailed Description
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Lymphoma, Follicular
Intervention ^ICMJE	Drug: HuMax-CD20
Study Arms / Comparison Groups
Publications *	Hagenbeek A, Gadeberg O, Johnson P, Pedersen LM, Walewski J, Hellmann A, Link BK, Robak T, Wojtukiewicz M, Pfreundschuh M, Kneba M, Engert A, Sonneveld P, Flensburg M, Petersen J, Losic N, Radford J. First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial. Blood. 2008 Jun 15;111(12):5486-95. Epub 2008 Apr 4.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Relapsed or refractory follicular lymphoma grade I-II Tumor verified to be CD20 positive CT scan showing demarcated lesions Exclusion Criteria: Previous treatment with rituximab resulting in less than partial response Previous radioimmunotherapy Previous stem cell transplantation Received the following treatments within 4 weeks prior to entering this study: Anti-cancer therapy Glucocorticosteroids unless less than 10 mg prednisolone/day Radiotherapy Received Mitomycin C or Nitrosoureas within 6 weeks prior to entering this trial HIV positivity Hepatitis B or hepatitis C Uncontrolled or chronic bacterial, fungal or viral infection Other cancer diseases, except certain skin cancers, cervix cancer and breast cancer Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases WHO performance status of 3 or 4 If you are participating in another trial with a different new drug 4 weeks before you enter this trial Current participation in any other clinical study Pregnant or breast-feeding women Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00092274
Responsible Party
Study ID Numbers ^ICMJE	Hx-CD20-001
Study Sponsor ^ICMJE	Genmab
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Genmab
Verification Date	January 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP