HuMax-CD20 in Chronic Lymphocytic Leukemia

• Status: Withdrawn
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Chronic Lymphocytic Leukemia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Antibodies, Monoclonal; Ofatumumab

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.