NCT00906945

Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia

Chemosensitization With Plerixafor Plus G-CSF in Relapsed or Refractory Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to test the combination of Plerixafor with G-CSF for chemosensitization in patients with relapsed or refractory AML.

Detailed description

In this study, we are seeking to target the leukemia microenvironment to overcome disease resistance. We hypothesize that by disrupting the interaction of leukemic blasts with the bone marrow microenvironment, we may sensitize leukemic blasts to the effects of cytotoxic chemotherapy. In this study, we seek to maximize blockage of the SDF-1/CXCR4 axis through the following: 1. Addition of G-CSF, which down regulates SDF-1 expression and acts synergistically with plerixafor in stem cell mobilization 2. Intravenous instead of subcutaneous dosing of plerixafor to improve kinetics of administration. 3. Dose escalation of plerixafor and twice daily dosing to maintain maximum CXCR4 blockade.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
DRUG	G-CSF
DRUG	Plerixafor
DRUG	Mitoxantrone
DRUG	Etoposide
DRUG	Cytarabine

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-11-01
• Completion: 2015-09-01
• First posted: 2009-05-21
• Last updated: 2017-04-04
• Results posted: 2017-04-04

Locations

3 sites across 1 country: United States