AMD3100 Plus Mitoxantrone, Etoposide and Cytarabine in Acute Myeloid Leukemia

Phase 1/2 Completed 52 enrolled Washington University School of Medicine

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is a phase I/II study to determine the safety and efficacy of AMD3100 when combined with mitoxantrone, etoposide, and cytarabine in patients with relapsed or refractory AML. We hypothesize that disrupting the interaction between AML blasts and the marrow microenvironment with AMD3100 may enhance the cytotoxic effect of chemotherapy.

Timeline

Start: 2007-07
Primary completion: 2010-06
Completion: 2010-06

Publications

Uy GL, Rettig MP, Motabi IH, McFarland K, Trinkaus KM, Hladnik LM, Kulkarni S, Abboud CN, Cashen AF, Stockerl-Goldstein KE, Vij R, Westervelt P, DiPersio JF. A phase 1/2 study of chemosensitization with the CXCR4 antagonist plerixafor in relapsed or refractory acute myeloid leukemia. Blood. 2012 Apr 26;119(17):3917-24. doi: 10.1182/blood-2011-10-383406. Epub 2012 Feb 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AMD3100	Small molecule	80 ug/kg	Subcutaneous
Subject	AMD3100	Small molecule	160 ug/kg	Subcutaneous
Subject	AMD3100	Small molecule	240 ug/kg	Subcutaneous
Background	Cytarabine	Small molecule	—	—
Background	Etoposide	Small molecule	—	—
Background	Mitoxantrone	Small molecule	—	—

AMD3100 Plus Mitoxantrone, Etoposide and Cytarabine in Acute Myeloid Leukemia

Summary

Timeline

Publications

Drugs

Indications