NCT01001143

Intravenous (IV) Decitabine and Oral Bexarotene for Acute Myelogenous Leukemia (AML)

A Phase I Dose Escalation Study of Intravenous Decitabine in Combination With Oral Bexarotene in Patients With Acute Myeloid Leukemia (AML)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to determine the safety and tolerability of combination decitabine and bexarotene during four cycles of therapy.

Detailed description

The investigators are seeking to study the combination of decitabine and bexarotene. These two agents have each shown efficacy in decreasing leukemic blast counts and restoring normal hematopoiesis via different mechanisms of action and with non-overlapping side-effect profiles. By combining these agents, the investigators hope to improve overall response rates. The investigators further hope to improve platelet and neutrophil counts in an even greater number of patients, thus treating two of the most important sources of morbidity and mortality in this patient population.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
DRUG	Decitabine
DRUG	Bexarotene

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-05-01
• Completion: 2014-05-01
• First posted: 2009-10-23
• Last updated: 2014-07-29

Locations

1 site across 1 country: United States