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.
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.
Study Type
EXPANDED_ACCESS
Patients will receive ponatinib 45 mg orally as a single dose once daily with or without food. Each patient will receive daily ponatinib until disease progression, unacceptable toxicity, or withdrawal of consent
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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
...and 23 more locations