The purpose of this study is to determine if a subcutaneous (SC) dosing schedule of veltuzumab can be established in NHL or CLL patients and to confirm the safety and efficacy of veltuzumab that was previously established when administered intravenously.
The first study of veltuzumab given IV weekly in NHL patients (IM-T-hA20-01) has shown excellent tolerability and even efficacy at weekly intravenous doses as low as 80-120 mg/m2 over 4 consecutive weeks. These clinical results confirm experiments laboratory studies. Laboratory studies using Veltuzumab administered subcutaneously showed potent activity based on B-cell depletion. The current study's goal is to determine if a subcutaneous (SC) dosing schedule of veltuzumab can be established in patients with NHL or CLL
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
veltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks.
Lewis Cancer Center and Research Pavilion
Savannah, Georgia, United States
Cancer Care at Saint Clare's/Saint Clares Hospital Oncology & Hematology Specialists, P.A.
Denville, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
New York Hospital Weill Cornell Medical Center
New York, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Safety/tolerability
safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years.
Time frame: over 2 years after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.