Expanded Access Program of AMN107 in Imatinib-resistant or Intolerant Adult Patients With Chronic Myeloid Leukemia
Chronic Myeloid Leukemia
About this trial
This is an expanded access trial for Chronic Myeloid Leukemia focused on measuring Chronic myeloid leukemia, AMN 107, Imatinib resistant or intolerant, nilotinib, enact
Eligibility Criteria
Inclusion criteria: Imatinib-resistant or -intolerant Philadelphia chromosome-positive chronic myeloid leukemia in blast crisis, accelerated phase, or chronic phase. Chronic myeloid leukemia patients who have been treated with an investigational tyrosine kinase inhibitor. Laboratory values within normal limits. Exclusion criteria: Impaired cardiac function. Acute or chronic liver or renal disease considered unrelated to tumor. Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol. Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval or to inhibit the metabolism of AMN107 (CYP3A4/5 inhibitors). Patients with a history of another malignancy that is currently clinically significant or currently requires active intervention. Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- University of South Alabama Cancer Research Institute
- Arizona Cancer Center
- City of Hope National Medical Center
- Antelope Valley Cancer Center
- Stanford University
- University of Colorado
- Rocky Mountain Cancer Center
- Georgetown University Medical Center-Lombardi Cancer Center
- Washington Cancer Institute
- Osler Medical Inc./Osler Clinical Research
- Advanced Medical Specialties
- Integrated Community
- Florida Hospital Cancer Institute
- MD Anderson Cancer Center
- Hematology Oncology Assoc.
- Emory University Cancer Institute
- Medical College of Georgia
- Rush University Medical Center
- Stroger Cook County Hospital
- University of Illinois at Chicago
- University of Chicago Hospital
- Loyola University Medical Center
- St. Francis Hospital & Health Centers
- University of Iowa Hospitals & Clinics
- Cancer Center of Kansas
- Louisville Oncology Research
- LSU Health Sciences Center
- St. Agnes Hospital
- University of Michigan
- Wayne State University
- St. John Hospital and Medical Center
- Mayo Clinic Hospital
- Southeast Nebraska Cancer Center
- Nebraska Methodist Cancer Center
- Nevada Cancer Institute
- Hackensack University Medical Center
- University of New Mexico Health Sciences Center
- Cancer Institute of New Mexico
- Roswell Park Cancer Institute
- Winthrop Hematology/Oncology
- Memorial Sloan Kettering Cancer Center
- Weill Cornell Medical Center
- Mount Sinai Medical Center
- University of Rochester Medical Center
- Duke University
- Wake Forest University
- Cancer Care Associates
- Cancer Care Associates
- Oregon Health Sciences University
- Western Pennsylvania Cancer Institute
- Charleston Hematology Oncology
- MUSC Hollings Cancer Center
- Three Medical Park
- Cancer Center of the Carolinas
- The Jones Clinic
- Vanderbilt University Medical Center
- UT Southwestern Medical Center
- Utah Cancer Specialists
- Swedish Cancer Institute
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