HuMax-CD20 in Chronic Lymphocytic Leukemia

Phase 1

Withdrawn

• Conditions: Chronic Lymphocytic Leukemia

• Registration Number: NCT00093314
• Lead Sponsor: GlaxoSmithKline

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

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2004-10-06
• Study First Submitted QC: 2004-10-07
• Study First Posted: 2004-10-08
• Status Verified: 2007-01
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Chronic Lymphocytic Leukemia
• Circulating lymphocytes above a specific level
• Circulating lymphocytes showing certain markers

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

University of Iowa, Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States