Granulocyte-colony Stimulating Factor (G-CSF) and Plerixafor Plus Sorafenib for Acute Myelogenous Leukemia (AML) With FLT3 Mutations

PHASE1CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

October 29, 2010

Primary Completion Date

March 23, 2017

Study Completion Date

March 23, 2017

Conditions
Acute Myelogenous LeukemiaLeukemia
Interventions
DRUG

G-CSF

10 microgram/kg subcutaneous injection based on adjusted ideal body weight and administered in the evening (prior to the Plerixafor). The 1st dose on day -1 and every other day for 7 total doses. G-CSF administration of 7 every-other-day doses will be repeated every 28 days.

DRUG

Plerixafor

A fixed dose of 240 mcg/kg subcutaneous injection in the abdomen, calculated on ideal body weight. The 1st dose on day -1 and every other day for 7 total doses. Plerixafor administration of 7 every-other-day doses will be repeated every 28 days.

DRUG

Sorafenib

"First dose will be given right after G-CSF and plerixafor injections. Drug doses will be separated by intervals of approximately 12 hours (+/-2 hours).~Dose Level 0 = 400 mg orally twice daily."

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

collaborator

Genzyme, a Sanofi Company

INDUSTRY

collaborator

Amgen

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Georgia Institute of Technology

OTHER

lead

M.D. Anderson Cancer Center

OTHER

NCT00943943 - Granulocyte-colony Stimulating Factor (G-CSF) and Plerixafor Plus Sorafenib for Acute Myelogenous Leukemia (AML) With FLT3 Mutations | Biotech Hunter | Biotech Hunter