HuMax-CD20 in Chronic Lymphocytic Leukemia - Tabular View

Tracking Information
First Received Date ^ICMJE	October 6, 2004
Last Updated Date	January 5, 2007
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 NCT00093314 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	HuMax-CD20 in Chronic Lymphocytic Leukemia
Official Title ^ICMJE	An Open-Labeled, International, Multicenter, Dose Escalating, Phase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Brief Summary	The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Chronic Lymphocytic Leukemia.
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	Chronic Lymphocytic Leukemia
Intervention ^ICMJE	Drug: HuMax-CD20
Study Arms / Comparison Groups
Publications *
* 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: Chronic Lymphocytic Leukemia Circulating lymphocytes above a specific level Circulating lymphocytes showing certain markers Exclusion Criteria: 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.
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	NCT00093314
Responsible Party
Study ID Numbers ^ICMJE	Hx-CD20-402
Study Sponsor ^ICMJE	Genmab
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Genmab
Verification Date	January 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP