This study will assess the safety and tolerability of milatuzumab (IMMU-115) when added to a standard regimen to prevent Graft vs. Host Disease (GVHD) in patients with hematologic malignancies undergoing stem cell transplant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Milatuzumab is a humanized anti-CD74 antibody that is administered intravenously.
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
All patients administered any dose of study drug will be included in the evaluation of safety
Safety will be measured by physical examinations and hematology and chemistry blood tests. Cardiac safety will be done using MUGA scans or echocardiograms. These assessments will be done routinely during treatment and up to 30 days after treatment and any change from baseline will be assessed. Long term safety will be assessed every 3 months after that for up to 1 year; any change from baseline will be assessed.
Time frame: Safety will be assessed by measuring the change from baseline during 7 days of treatment and up to 30 days after treatment
Determine the therapeutic efficacy of milatuzumab in this patient population
Acute GVHD will be assessed at days +30 and +100 by laboratory testing. Chronic GVHD assessment will be performed at days +100, +270 \& +365 after stem cell transplant.
Time frame: Efficacy will be assessed 30 days after treatment.
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