Status:
WITHDRAWN
Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lymphoma, Follicular
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).
Eligibility Criteria
Inclusion
- Relapsed or refractory follicular lymphoma grade I-II
- Tumor verified to be CD20 positive
- CT scan showing demarcated lesions
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00092274
Start Date
September 1 2004
End Date
January 1 2005
Last Update
April 21 2015
Active Locations (1)
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1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242