Status:
WITHDRAWN
HuMax-CD20 in Chronic Lymphocytic Leukemia
Lead Sponsor:
GlaxoSmithKline
Conditions:
Chronic Lymphocytic Leukemia
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 Chronic Lymphocytic Leukemia.
Eligibility Criteria
Inclusion
- Chronic Lymphocytic Leukemia
- Circulating lymphocytes above a specific level
- Circulating lymphocytes showing certain markers
Exclusion
- Previous treatment with rituximab or alemtuzumab within 6 months prior to enrollment in study.
- Previous stem cell transplantation.
- Received any of the following treatments within 4 weeks prior to entering this trial: A) Anti-cancer therapy, B) Glucocorticoids unless less than 10 mg per day, C) Radiotherapy.
- HIV positivity.
- Hepatitis B or hepatitis C.
- Other cancerous diseases, except certain skin cancers and cervix cancer.
- Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, heart, hormonal, nerve or blood diseases.
- Participation in another trial with a different new drug 4 weeks prior to enrollment in study.
- Current participation in any other clinical study.
- Pregnant or breast-feeding women.
- Women of childbearing age who are unable or unwilling to use adequate contraception.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00093314
Start Date
October 1 2004
End Date
January 1 2007
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