The Humanized Monoclonal Antibody Milatuzumab for Refractory Chronic Lymphocytic Leukemia (CLL)

• Status: Unknown status
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Milatuzumab is effective in patients with refractory chronic lymphocytic leukemia, and also to find out in which range of doses is a response seen.

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

Details

• Lead Sponsor: Kaplan Medical Center
• Collaborators: Gilead Sciences; Immunomedics, Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

Inclusion Criteria:

• B-CLL confirmed according to NCI criteria

• CLL relapsed or refractory to prior antineoplastic therapy

• Signs of progressive disease; at least one:

• B symptoms

• lymphocyte doubling time of < 6 months

• symptomatic lymphadenopathy or splenomegaly

• cytopenias due to bone marrow failure)

• Age > 18 years, and less then 80

• Serum ALAT, ASAT, bilirubin, creatinine < 2x upper limit of normal

• Life expectancy > 6 months

• Patient's written informed consent

Exclusion Criteria:

• Active bacterial or viral infection

• Hypersensitivity to humanized monoclonal antibodies

• Concurrent antineoplastic treatment for CLL or other malignant disease

• Absolute neutrophil count < 1.5 K/