A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies
Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive), Hypereosinophilic Syndrome
About this trial
This is an interventional treatment trial for Chronic Myelogenous Leukemia focused on measuring CML in blast crisis, CML in chronic phase, CML in accelerated phase, Gleevec resistance, Gleevec intolerant, Gleevec and CML, imatinib resistance, imatinib intolerant, Hypereosinophilic Syndrome, Systemic Mastocytosis, Chronic eosinophilic syndrome, Philadelphia chromosome positive acute lymphoblastic leukemia, HES, CEL, CML, SM, Ph+ ALL refractory to standard therapy, Ph+ALL relapsed, AMN107A
Eligibility Criteria
Inclusion Criteria: Main inclusion criteria include: Patients with CML in blast crisis, CML in accelerated phase defined as never in blast crisis phase, or CML in chronic phase defined as never been in blast crisis phase or accelerated phase who have: *developed progressive disease during therapy with at least 600 mg of imatinib per day, -OR- *patients with CML on imatinib therapy, at any dose, developing progressive disease and the presence of a genetic mutation likely to result in imatinib resistance -OR- *have developed an intolerance to imatinib Relapsed or refractory Ph+ ALL Hypereosinophilic syndrome/chronic eosinophilic leukemia. Systemic mastocytosis who have a clinical indication for treatment. Prior imatinib therapy for patients with Ph+ ALL, HES/CEL and SM is permitted but is not required CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib-resistance or intolerance are eligible Written informed consent prior to any study procedures being performed Exclusion Criteria: Impaired cardiac function Patients with severe/chronic or uncontrolled medical conditions (including but not limited to diabetes, infections, GI impairment, CNS infiltration, liver and kidney disease) Prior and concomitant use of certain medications (including but not limited to warfarin, chemotherapy, hematopoietic colony-stimulating growth factors, medications that can affect electrocardiogram test results, other investigational drugs ) Women who are pregnant or breastfeeding Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention. Patients unwilling to comply with the protocol. Known diagnosis of human immunodeficiency virus (HIV) infection Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- City of Hope National Medical Center
- Stanford University Medical Center
- University of Colorado Hospital
- H. Lee Moffitt Cancer Center & Research Institute Dept.of H. Lee Moffitt
- University of Chicago Medical Center Dept. of U. of Chicago Hosp(3)
- University of Illinois at Chicago Divisionof Hematology/Oncology
- Indiana Blood and Marrow Institute Dept of Indiana Blood&Mar (2)
- Ochsner Clinic Foundation
- Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Div.of Hematologic Malignancie
- Dana Farber Cancer Institute
- University of Michigan Health System Clinical Trials Office
- Wayne State University
- Mayo Clinic - Rochester
- Hackensack University Medical Center
- Roswell Park Cancer Institute Rosewell SC
- Memorial Sloan Kettering Cancer Center
- University of Rochester Medical Center
- Duke University Medical Center
- Wake Forest University Baptist Medical Center
- Oregon Health Sciences University
- The Jones Clinic
- Vanderbilt University Medical Center, Clinical Trials Center Investigational Drug Services
- MD Anderson Cancer Center/University of Texas
- Swedish Cancer Institute
- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
CML-CP With Prior Imatinib Only
CML-AP With Prior Imatinib Onl
CML-CP
Imatinib-resistant / intolerant PH+ CML-CP patients
Imatinib-resistant / intolerant PH+ CML-AP patients
Imatinib-resistant / intolerant PH+ CML-CP patients