Acute Myeloid Leukemia (AML)
|Closed||De Novo Acute Myeloid Leukemia (AML)||Phase I||
The purpose of this research study is to determine if Plerixafor can release cells into the blood and make them more sensitive to killing by Cytarabine and Daunorubicin, an anti-cancer drug regimen referred to as "7+3" that is commonly used in treating acute myeloid leukemia (AML). In this study, Plerixafor will be added to treatment with Cytarabine and Daunorubicin. Subjects will be monitored to see how well they tolerate the use of these drugs together and how well they work to treat the leukemia.
The study is divided into Part 1 and Part 2. The purpose of Part 1 of the study is to find the highest dose of Plerixafor that can be given safely with Cytarabine and Daunorubicin. The purpose of Part 2 of the study is to collect additional safety information for Plerixafor when used with Cytarabine and Daunorubicin to see the effects the combination treatment has on the subject and his/her leukemia.
|Ages Eligible for Study:||18 Years to 70 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- Provide signed, dated informed consent prior to any protocol-specific procedures.
- Have a diagnosis of previously-untreated AML, defined as >20% myeloblasts on the marrow aspirate or peripheral blood differential, with or without extramedullary involvement, with confirmatory immunophenotyping or immunocytochemistry (e.g., myeloperoxidase), documented within 14 days of enrollment
- Have Eastern Cooperative Oncology Group (ECOG) performance status (Appendix A) score of 0, 1, or 2.
- Toxicities from all prior treatments have resolved to baseline or δ Grade 1 prior to first dose of study drugs.
- Are surgically or biologically sterile or willing to practice acceptable birth control, as follows: Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Women of child bearing potential must have a negative serum pregnancy test at the time of enrollment. Acceptable methods of birth control include oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives and abstinence.
- Males must agree to abstain from sexual activity or agree to utilize a medially-approved contraception method during and for 3 months afer the treatment period.
- Have adequate renal and hepatic function, as indicated by the following laboratory values: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) δ2.5 - upper limit of normal (ULN); Estimated creatinine clearance (CrCl) of > 50mL/min, as calculated by the Cockcroft-Gault equation (Appendix F); total bilirubin δ1.5-ULN (except in patients with Gilbert Syndrome, in whom direct bilirubin must be δ1.5-ULN), International Normalized Ratio (INR) δ1.5
- Have adequate cardiac function, as measured by left ventricular ejection fraction (LVEF) ε40% on echocardiography or multigated acquisition (MUGA) scan or similar radionuclide angiographic scan
- Be able to comply with study procedures and follow-up examinations.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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