Spots Global Cancer Trial Database for Expanded Access Program of Ponatinib
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Trial Identification
Brief Title: Expanded Access Program of Ponatinib
Official Title: Expanded Access Program of Ponatinib (AP24534) for Patients With Refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia
Study ID: NCT01592136
Interventions
Study Description
Brief Summary: This protocol will allow expanded access of ponatinib to patients ≥18 years with chronic myeloid leukemia (CML) any phase or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) who have failed all available treatment options.
Detailed Description: This protocol will allow expanded access of ponatinib to patients ≥18 years with CML or Ph+ALL who have failed all available treatment options. Patients with chronic (CP) or accelerated phase (AP) CML must be previously treated with and resistant or intolerant to imatinib, dasatinib and nilotinib or develop the T315I mutation after any tyrosine kinase inhibitor (TKI) therapy. Patients with blast phase (BP) CML and Ph+ ALL must be previously treated with and resistant or intolerant to imatinib and dasatinib or develop the T315I mutation after any TKI therapy. No formal analysis will be performed on any data obtained. Safety information will be collected and adverse events will be tabulated for reporting purposes only.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Moores UCSD Cancer Center, Site #165, La Jolla, California, United States
Southern California Permanente Medical Group, Site #161, San Marcos, California, United States
Kaiser Permanente Medical Center, Site #158, Vallejo, California, United States
Smilow Cancer Hospital at Yale New Haven, Site #182, New Haven, Connecticut, United States
Cancer Institute of Florida, Site #187, Altamonte Springs, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Site #017, Tampa, Florida, United States
Emory University, Site # 058, Atlanta, Georgia, United States
University of Chicago Medical Center, Site #001, Chicago, Illinois, United States
Indiana Blood and Marrow Transplantation, Site #138, Indianapolis, Indiana, United States
Norton Cancer Institute, Site #142, Louisville, Kentucky, United States
University of Maryland, Site #040, Baltimore, Maryland, United States
Tufts Medical Center, Site #141, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Site 008, Boston, Massachusetts, United States
University of Massachusetts Worcester, Site #152, Worcester, Massachusetts, United States
University of Michigan Health System, Site #011, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Site #034, Detroit, Michigan, United States
Mayo Clinic, Site #044, Rochester, Minnesota, United States
Freeman Cancer Institute, Site #190, Joplin, Missouri, United States
Washington University School of Medicine, Site 007, Saint Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center, Site 128, Hackensack, New Jersey, United States
Roswell Park Cancer Institute, Site #029, Buffalo, New York, United States
Weill Cornell Medical College - New York Presbyterian Hospital, Site #006, New York, New York, United States
University of Rochester, Site 137, Rochester, New York, United States
Duke University Medical Center, Site 003, Durham, North Carolina, United States
Jewish Hospital, Site #175, Cincinnati, Ohio, United States
Oregon Health & Science University (OHSU), Site 048, Portland, Oregon, United States
Hospital of the University of Pennsylvania, Site #013, Philadelphia, Pennsylvania, United States
Jeanes Hospital of TUHS, Site #127, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Site #148, Charleston, South Carolina, United States
Tennesse Oncology, PLLC, Site # 076, Nashville, Tennessee, United States
The University of Texas M.D. Anderson Cancer Center, Site #005, Houston, Texas, United States
Huntsman Cancer Institute at the University of Utah, Site #043, Salt Lake City, Utah, United States
Seattle Cancer Care Alliance, Site #100, Seattle, Washington, United States
Contact Details
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