A Phase I/II Study of Immunotherapy With Milatuzumab (hLL1) in Patients With Chronic Lymphocytic Leukemia (CLL)
Milatuzumab (hLL1, IMMU-115), a humanized anti-CD74 monoclonal antibody. Dose escalation
will utilize 4 planned dose regimens with 4.0 or 8.0 mg/kg doses administered intravenously
either twice weekly (days 1 and 4) or thrice weekly (days 1, 3 and 5) for 4 consecutive
weeks. The four planned dose regimens will be labeled as dose level 1 to 4 corresponding to
increasing levels of the total dose of milatuzumab.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of the anti-CD74 antibody will be evaluated based upon physical examinations, hematology and chemistry laboratory evaluations and toxicity events
over first 12 weeks
Yes
William Wegener, MD, PhD
Study Chair
Immunomedics, Inc.
United States: Food and Drug Administration
IM-T-hLL1-02
NCT00603668
August 2008
February 2013
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Georgetown University Hospital Lombardi Cancer Center | Washington, District of Columbia 20007 |
M. D. Anderson Cancer Center | Orlando, Florida 32806 |