This will be an open label, multiple center, non-randomized, dose-escalation Phase I/II trial, designed to evaluate the safety and effectiveness of a repeated, outpatient regimen utilizing IMMU-hLL2 intact monoclonal antibody IgG labeled with different doses of 90Y for the treatment of patients B-cell lymphoma (NHL).
90Y-labeled hLL2 will be administered according to a schedule based upon whether or not a patient had prior high-dose chemotherapy with a marrow or stem cell transplant. Patients with both indolent and aggressive types of NHL will be enrolled at each dose level without segregation. However, at the conclusion of the trial, with the maximum tolerated dose (MTD) defined, a minimum number of 6 patients with indolent NHL, 6 patients with aggressive NHL, and 6 patients with \>25% bone marrow involvement will be studied at that dose level.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
weekly dosing for either 2 or 3 weeks
Research Unit 463 INSERM
Nantes, Cedex, France
Service des Maladies du Sang
Lille, France
University Hospital Dresden
Dresden, Germany
Klinikum der Georg-August-Universitat Gottingen
Göttingen, Germany
Safety will be evaluated from physical examinations, hematology and chemistry testing and toxicity evaluation
Time frame: First 12 weeks, total 5 years
Determine maximum tolerated dose (MTD)
Time frame: first 12 weeks
Evaluate the immunogenicity and safety of repeated infusions of 90Y-hLL2 in NHL patients.
Time frame: 6 weeks, 12 weeks, every 3 months if HAHA elevated
Determine the therapeutic effects, in terms of objective response rate and duration, of the therapeutic agent in NHL patients.
Time frame: 6 wks, 12 wks, every 3 mos for 5 years
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Universitatsklinikum University of Saarland
Homburg/Saar, Germany