Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia
Status:
Terminated
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
Summary
Subjects have acute promyelocytic leukemia (APL) that has come back (relapsed) after initial
treatment or has not gone away with initial therapy. This research study involves testing an
investigational drug called Tamibarotene in combination with standard treatment for relapsed
APL called arsenic trioxide. Tamibarotene has been approved in Japan to treat patients with
relapsed APL since April 2005. Tamibarotene is in the same family of drugs as all-trans
retinoic acid (ATRA), a medication that subjects received previously in their treatment. ATRA
and tamibarotene both cause the APL cells to differentiate (or become) normal non-leukemia
cells. Laboratory studies of tamibarotene have shown to be effective in APL. The purpose of
this study is to determine if tamibarotene in combination with arsenic trioxide is safe and
effective.