Safety, Efficacy, & Pharmacokinetic Study of Tamibarotene to Treat Patients With Relapsed or Refractory APL
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
This is a Phase II, open-label, non-randomized study to evaluate the safety, efficacy, and
pharmacokinetics of tamibarotene in adult patients with relapsed or refractory acute
promyelocytic leukemia (APL) following treatment with all-trans-retinoic acid (ATRA) and
arsenic trioxide (ATO). Patients must have received and failed therapy with ATRA and ATO.
Treatment may have been administered either as combination therapy or sequentially as single
agents. Patients who are intolerant to either drug are eligible for this study.