Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of Amplimexon® (Imexon for Injection) for the Treatment of Previously Treated Follicular and Aggressive Lymphoma in Adults
The purpose of this study is to determine whether Amplimexon (imexon for injection) is effective in the treatment of indolent and aggressive lymphomas that have progressed after treatment with standard therapies.
A phase II exploratory trial of imexon in lymphoma is justified by: (1) the observation of
clinical activity (partial response to the drug observed in phase I testing in a subject
with refractory indolent lymphoma); (2) the finding that imexon prevents the development of
human immunoblastic lymphoma in SCID mice; (3) the finding that lymphoma cell lines are
killed by readily achievable doses; and (4) translational studies implicating the importance
of the redox state of the cancer cell.
The dose and schedule chosen (1000 mg/m2 daily X 5 days every 3 weeks) is based on
tolerability and subject acceptance in prior AmpliMed phase I studies.
The planned correlative studies should help to identify potential biomarkers for response to
imexon and provide further insight into potential mechanisms of imexon action hypothesized
from results of prior laboratory studies.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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