A Phase I/II Study of Veltuzumab (IMMU-106, hA20), a Humanized Anti-CD20 Monoclonal Antibody, Combined With Milatuzumab (IMMU-115, hLL1), a Humanized Anti-CD74 Monoclonal Antibody, in Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma
A phase I/II study of veltuzumab combined with milatuzumab in relapsed and refractory
non-Hodgkin's lymphoma. Both agents are well-tolerated in early phase clinical testing with
infusion reactions as the primary observed toxicity. Preclinical testing in vitro and in
vivo have demonstrated single agent activity for both veltuzumab and milatuzumab. In mantle
cell lymphoma cell lines and SCID mouse models, synergist effects were observed when
milatuzumab was combined with rituximab. Veltuzumab has several advantages over rituximab
including slower off-rates, shorter infusion times, higher potency, and improved therapeutic
responses in animal models. Previous and ongoing clinical investigations support the concept
of combining monoclonal antibodies in NHL.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine dose limiting toxicity (DLT)and maximum tolerated dose (MTD)for phase I and overall response rate for phase II along with defining toxicities for the combination.
up to 2 years
Yes
Beth Christian, MD
Principal Investigator
Ohio State University
United States: Food and Drug Administration
OSU-09024
NCT00989586
September 2009
Name | Location |
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Ohio State University Comprehensive Cancer Center | Columbus, Ohio |