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

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

This study has been completed.
Information provided by Genmab

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma
Official Title ^†	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 ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Lymphoma, Follicular
Intervention ^†	Drug: HuMax-CD20
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†
Start Date ^†
Completion Date
Eligibility Criteria ^†	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 ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00092274
Organization ID	Hx-CD20-001
Secondary IDs ^††
Study Sponsor ^†	Genmab
Collaborators ^††
Investigators ^†
Information Provided By	Genmab
Verification Date	January 2005
First Received Date ^†	September 22, 2004
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.