Expanded Access Program of Ponatinib
1 other identifier
expanded_access
N/A
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
33 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2012
CompletedFirst Posted
Study publicly available on registry
May 7, 2012
CompletedFebruary 6, 2018
February 1, 2018
May 3, 2012
February 5, 2018
Conditions
Keywords
Interventions
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
Eligibility Criteria
You may qualify if:
- CP-CML and AP-CML patients previously treated with and resistant or intolerant to imatinib, dasatinib and nilotinib or those who developed the T315I mutation after any TKI therapy. BP-CML and Ph+ ALL patients previously treated with and resistant or intolerant to imatinib and dasatinib or those who developed the T315I mutation after any TKI therapy.
- Patients must be ≥ 18 years old.
- Provide written informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Men and women of childbearing potential must agree to effective contraception from the time of signing informed consent through the Follow-up Visit, approximately 30 days after last dose of ponatinib.
You may not qualify if:
- Are eligible for an ongoing and accessible clinical trial of ponatinib
- Have not adequately recovered from AEs due to agents previously administered
- Require concurrent treatment with immunosuppressive agents, other than corticosteroids prescribed for a short course of therapy.
- Have previously been treated with ponatinib.
- Have significant or active cardiovascular disease, specifically including, but not restricted to:
- Myocardial infarction within 3 months prior to first dose of ponatinib,
- History of clinically significant atrial arrhythmia or any ventricular arrhythmia,
- Unstable angina within 3 months prior to first dose of ponatinib,
- Congestive heart failure within 3 months prior to first dose of ponatinib.
- Have abnormal QTcF (\> 450 ms for males or \> 470 ms for females)
- Have a significant bleeding disorder unrelated to CML or Ph+ ALL.
- Have a history of pancreatitis or alcohol abuse
- Have elevated amylase or lipase (\> 1.5 x ULN for institution) at entry.
- Have inadequate hepatic function or any of the following:
- Total bilirubin \> 1.5 x ULN for institution at entry
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Moores UCSD Cancer Center, Site #165
La Jolla, California, 92093, United States
Southern California Permanente Medical Group, Site #161
San Marcos, California, 92069, United States
Kaiser Permanente Medical Center, Site #158
Vallejo, California, 94589, United States
Smilow Cancer Hospital at Yale New Haven, Site #182
New Haven, Connecticut, 06510, United States
Cancer Institute of Florida, Site #187
Altamonte Springs, Florida, 32792, United States
H. Lee Moffitt Cancer Center & Research Institute, Site #017
Tampa, Florida, 33612, United States
Emory University, Site # 058
Atlanta, Georgia, 30322, United States
University of Chicago Medical Center, Site #001
Chicago, Illinois, 60637, United States
Indiana Blood and Marrow Transplantation, Site #138
Indianapolis, Indiana, 46237, United States
Norton Cancer Institute, Site #142
Louisville, Kentucky, 40202, United States
University of Maryland, Site #040
Baltimore, Maryland, 21201, United States
Tufts Medical Center, Site #141
Boston, Massachusetts, 02111, United States
Dana-Farber Cancer Institute, Site 008
Boston, Massachusetts, 02215, United States
University of Massachusetts Worcester, Site #152
Worcester, Massachusetts, 01655, United States
University of Michigan Health System, Site #011
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute, Site #034
Detroit, Michigan, 48201, United States
Mayo Clinic, Site #044
Rochester, Minnesota, 55905, United States
Freeman Cancer Institute, Site #190
Joplin, Missouri, 64804, United States
Washington University School of Medicine, Site 007
St Louis, Missouri, 63110, United States
John Theurer Cancer Center at Hackensack University Medical Center, Site 128
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute, Site #029
Buffalo, New York, 14263, United States
Weill Cornell Medical College - New York Presbyterian Hospital, Site #006
New York, New York, 10065, United States
University of Rochester, Site 137
Rochester, New York, 14627, United States
Duke University Medical Center, Site 003
Durham, North Carolina, 27710, United States
Jewish Hospital, Site #175
Cincinnati, Ohio, 45236, United States
Oregon Health & Science University (OHSU), Site 048
Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania, Site #013
Philadelphia, Pennsylvania, 19104, United States
Jeanes Hospital of TUHS, Site #127
Philadelphia, Pennsylvania, 19111, United States
Medical University of South Carolina, Site #148
Charleston, South Carolina, 29425, United States
Tennesse Oncology, PLLC, Site # 076
Nashville, Tennessee, 37203, United States
The University of Texas M.D. Anderson Cancer Center, Site #005
Houston, Texas, 77030, United States
Huntsman Cancer Institute at the University of Utah, Site #043
Salt Lake City, Utah, 84112, United States
Seattle Cancer Care Alliance, Site #100
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2012
First Posted
May 7, 2012
Last Updated
February 6, 2018
Record last verified: 2018-02