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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

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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.




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