Status:
COMPLETED
Study of Plerixafor Combined With Cytarabine and Daunorubicin in Patients With Newly Diagnosed Acute Myeloid Leukemia
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to determine if plerixafor can make cells more sensitive to killing by cytarabine and daunorubicin, an anti-cancer drug regimen referred to as "7+3" that is commo...
Eligibility Criteria
Inclusion
- Provide signed, dated informed consent prior to any protocol-specific procedures.
- Have a diagnosis of newly diagnosed 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 after 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 ≤1.5-ULN (except in patients with Gilbert Syndrome, in whom direct bilirubin must be ≤1.5-ULN), International Normalized Ratio (INR) ≤1.5 after discontinuation of anticoagulants.
- Have adequate cardiac function, as measured by left ventricular ejection fraction (LVEF) ≥40% on echocardiography or multigated acquisition (MUGA) scan or similar radionuclide angiographic scan.
- Be able to comply with study procedures and follow-up examinations.
Exclusion
- Have received previous systemic treatment for leukemia or antecedent hematologic disorder (AHD), other than hydroxyurea or hematopoietic growth factors. Treatment with hydroxyurea within 2 weeks of screening is allowed but must be discontinued at least 24 hours prior to the first dose of study drugs.
- Have received prior treatment with plerixafor, cytarabine, or any anthracycline.
- Have a diagnosis of acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 or World Health Organization (WHO) classification of APL with t(15;17)(q(22;q12), or Bcr-Abl positive leukemia.
- For patients \< 50 years of age, have cytogenetics associated with good prognosis \[(t(8;21)q(22;22), t(15;17),inv(16)(p13;q22)\]. (Testing for these mutations must be performed on blood or Bone Marrow prior to study registration.
- Have had a hematopoietic stem cell transplant (HSCT).
- Have an absolute blast count of the following at the time of first dose of chemotherapy, despite cytoreduction with hydroxyurea or leukapheresis:
- \>50 x 10\^9/L for patients not enrolled in a G-CSF-containing cohort
- \>25 x 10\^9/L for patients enrolled in a G-CSF-containing cohort
- Have central nervous system (CNS) leukemia (Only patients with suspected CNS leukemia must undergo lumbar puncture.)
- Have any of the following within the last 12 months: unstable supraventricular arrhythmia (e.g., hemodynamic instability) or has a pacemaker; Any ventricular arrhythmia, other than occasional premature ventricular contractions; Congestive heart failure (controlled or uncontrolled); Myocardial infarction, ischemia, stable coronary artery disease, or angina; Uncontrolled hypertension; Syncope with either a known cardiovascular or an unknown etiology.
- Have a pre-existing disorder predisposing the patient to serious or life-threatening infection (e.g., cystic fibrosis, congenital or acquired immunodeficiency, bleeding disorder, or cytopenias).
- Have the need for anticoagulant therapy.
- Have a significant medical or psychiatric disorder that would interfere with consent, study participation, or follow-up.
- Have an active acute or chronic systemic fungal, bacterial, viral, or other infection (i.e., exhibiting ongoing signs/symptoms related to the infection \[except isolated fever\] and without improvement, despite appropriate antibiotics or other treatment).
- Have severe concurrent diseases (e.g., a history of serious organ dysfunction or disease) that may place the patient at undue risk to undergo induction therapy per protocol, or obscure assessments of drug safety.
- Have a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent, with the following exceptions:
- Patients with treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, if definitive treatment for the condition has been completed; or
- Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values after treatment with curative intent.
- Have known human immunodeficiency virus (HIV) positivity or evidence of active viral hepatitis.
- Are pregnant or breastfeeding.
- Are known to have an allergy to any component of the study drug regimen
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00990054
Start Date
December 1 2009
End Date
March 1 2012
Last Update
March 24 2015
Active Locations (8)
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1
Duarte, California, United States
2
Boston, Massachusetts, United States
3
Ann Arbor, Michigan, United States
4
St Louis, Missouri, United States