90Y-hLL2
Biologicalweekly dosing for either 2 or 3 weeks
Other names: epratuzumab, hLL2
NCT Number: NCT00421395
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).
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Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Research Unit 463 INSERM, Nantes, Cedex, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
weekly dosing for either 2 or 3 weeks
Other names: epratuzumab, hLL2
Time frame: First 12 weeks, total 5 years
Time frame: first 12 weeks
Time frame: 6 weeks, 12 weeks, every 3 months if HAHA elevated
Time frame: 6 wks, 12 wks, every 3 mos for 5 years
Gilead Sciences
Industry
Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized IMMU-LL2: Treatment With 90Y-hLL2 IgG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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