Status:
COMPLETED
Granulocyte-colony Stimulating Factor (G-CSF) and Plerixafor Plus Sorafenib for Acute Myelogenous Leukemia (AML) With FLT3 Mutations
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Bayer
Genzyme, a Sanofi Company
Conditions:
Acute Myelogenous Leukemia
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to learn the most tolerable dose of Nexavarâ (sorafenib) when given in combination with Mobozilâ (plerixafor) and Neupogenâ (filgrastim) to patients with AM...
Detailed Description
The Study Drugs: Sorafenib is a type of drug called a multikinase inhibitor. It is designed to interfere with the parts of cancer cells that are involved in the sending of chemical messages and helpi...
Eligibility Criteria
Inclusion
- Patients will be 18 years of age or older.
- Patients must have relapsed/refractory leukemia with FLT3 (ITD) mutations. Patients with AML FLT3 mutations who are not eligible for frontline standard therapy, or who refuse to be treated with intensive chemotherapy, may be eligible.
- Serum biochemical values with the following limits unless considered due to leukemia: creatinine \</= 1.5 mg/dl; total bilirubin \</= 1.5 mg/dL, unless increase is due to hemolysis or congenital disorder; or transaminases (SGPT) \</= 2.5 x upper limit of normal (ULN)
- Able to take oral medication.
- Able to understand and provide signed informed consent.
- Ejection fraction at screening must be \>/=50%.
- Performance status \< 3, unless directly related to leukemic disease process as determined by the Principal Investigator.
Exclusion
- Subjects with acute promyelocytic leukemia.
- Patients with absolute blast count \> 20 k/uL.
- Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
- Men not willing to maintain adequate contraception with their partner over the entire course of the study.
- Hypertension \> 140 mmHg systolic OR \> 90 mmHg diastolic with or without antihypertensive therapy.
- Cardiac disease: Congestive heart failure \> class II New York Heart Association (NYHA). Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any of the excipients.
- Known human immunodeficiency virus (HIV) infection or active Hepatitis B or C.
- Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event \>/= CTCAE Grade 2 within 4 weeks of first dose of study drug.
- Any other hemorrhage/bleeding event \>/= CTCAE Grade 3 within 4 weeks of first dose of study drug.
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
- Currently using St. John's Wort or rifampin.
- Known or suspected allergy to sorafenib or any agent given in the course of this trial.
- Active clinically serious and uncontrolled infection \> CTCAE Grade 2.
- Serious non-healing wound, ulcer, or bone fracture.
- Patients currently receiving any other standard or investigational treatment for their hematologic malignancy.
Key Trial Info
Start Date :
October 29 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00943943
Start Date
October 29 2010
End Date
March 23 2017
Last Update
March 29 2017
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030