HuMax-CD20 in Chronic Lymphocytic Leukemia - Tabular View

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HuMax-CD20 in Chronic Lymphocytic Leukemia

This study has been completed.

Study NCT00093314. Last updated on January 5, 2007. Information provided by Genmab

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

Descriptive Information Fields
Brief Title ^†	HuMax-CD20 in Chronic Lymphocytic Leukemia
Official Title ^†	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 ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Chronic Lymphocytic Leukemia
Intervention ^†	Drug: HuMax-CD20
MEDLINE PMIDs
Links

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

Administrative Information Fields
NCT ID ^†	NCT00093314
Organization ID	Hx-CD20-402
Secondary IDs ^††
Study Sponsor ^†	Genmab
Collaborators ^††
Investigators ^†
Information Provided By	Genmab
Verification Date	January 2007
First Received Date ^†	October 6, 2004
Last Updated Date	January 5, 2007

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