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Expanded Access Program of Ponatinib (AP24534) for Patients With Refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia


N/A
18 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia (CML), Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

Thank you

Trial Information

Expanded Access Program of Ponatinib (AP24534) for Patients With Refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia


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.


Main

Inclusion Criteria:



1. 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.

2. Patients must be ≥ 18 years old.

3. Provide written informed consent.

4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

5. 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.

Main Exclusion Criteria:

Patients are not eligible for participation in the study if they meet any of the following
exclusion criteria:

1. Are eligible for an ongoing and accessible clinical trial of ponatinib

2. Have not adequately recovered from AEs due to agents previously administered

3. Require concurrent treatment with immunosuppressive agents, other than
corticosteroids prescribed for a short course of therapy.

4. Have previously been treated with ponatinib.

5. 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.

6. Have abnormal QTcF (> 450 ms for males or > 470 ms for females)

7. Have a significant bleeding disorder unrelated to CML or Ph+ ALL.

8. Have a history of pancreatitis or alcohol abuse

9. Have elevated amylase or lipase (> 1.5 x ULN for institution) at entry.

10. Have inadequate hepatic function or any of the following:

- Total bilirubin > 1.5 x ULN for institution at entry

- Alanine aminotransferase and aspartate aminotransferase > 2.5 x ULN for
institution at entry

- Prothrombin time >1.5 x ULN for institution at entry

11. Have inadequate renal function or serum creatinine > 2.5 x ULN for institution at
entry

12. Have uncontrolled hypertriglyceridemia or triglycerides > 450 mg/dL at entry.

13. Have malabsorption syndrome or other gastrointestinal illness that could affect
absorption of orally administered ponatinib.

14. Women who are pregnant or lactating.

15. Underwent major surgery within 14 days prior to the first dose of ponatinib.

16. Have ongoing or active infection (including known history of human immunodeficiency
virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV]).

17. Suffer from any condition or illness that, in the opinion of the Investigator would
compromise patient safety or interfere with the evaluation of the safety of the study
drug.

Type of Study:

Expanded Access

Study Design:

N/A

Authority:

United States: Food and Drug Administration

Study ID:

AP24534-12-901

NCT ID:

NCT01592136

Start Date:

Completion Date:

Related Keywords:

  • Chronic Myeloid Leukemia (CML)
  • Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
  • Ponatinib
  • Tyrosine kinase inhibitor
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

Name

Location

H. Lee Moffitt Cancer Center & Research Institute, Site #017Tampa, Florida  33612
Roswell Park Cancer Institute, Site #029Buffalo, New York  14263
Huntsman Cancer Institute at the University of Utah, Site #043Salt Lake City, Utah  84112
University of Chicago Medical Center, Site #001Chicago, Illinois  60637
Emory University, Site # 058Atlanta, Georgia  30322
University of Maryland, Site #040Baltimore, Maryland  21201
Dana-Farber Cancer Institute, Site 008Boston, Massachusetts  02215
University of Michigan Health System, Site #011Ann Arbor, Michigan  48109
Karmanos Cancer Institute, Site #034Detroit, Michigan  48201
Washington University School of Medicine, Site 007St. Louis, Missouri  63110
University of Rochester, Site 137Rochester, New York  14627
Duke University Medical Center, Site 003Durham, North Carolina  27710
The University of Texas M.D. Anderson Cancer Center, Site #005Houston, Texas  77030
Moores UCSD Cancer Center, Site #165La Jolla, California  92093
Southern California Permanente Medical Group, Site #161San Marcos, California  92069
Kaiser Permanente Medical Center, Site #158Vallejo, California  94589
Smilow Cancer Hospital at Yale New Haven, Site #182New Haven, Connecticut  06510
Cancer Institute of Florida, Site #187Altamonte Springs, Florida  32792
Indiana Blood and Marrow Transplantation, Site #138Indianapolis, Indiana  46237
Norton Cancer Institute, Site #142Louisville, Kentucky  40202
Tufts Medical Center, Site #141Boston, Massachusetts  02111
University of Massachusetts Worcester, Site #152Worcester, Massachusetts  01655
Mayo Clinic, Site #044Rochester, Minnesota  55905
Freeman Cancer Institute, Site #190Joplin, Missouri  64804
John Theurer Cancer Center at Hackensack University Medical Center, Site 128Hackensack, New Jersey  07601
Weill Cornell Medical College - New York Presbyterian Hospital, Site #006New York, New York  10065
Jewish Hospital, Site #175Cincinnati, Ohio  45236
Oregon Health & Science University (OHSU), Site 048Portland, Oregon  97239
Hospital of the University of Pennsylvania, Site #013Philadelphia, Pennsylvania  19104
Jeanes Hospital of TUHS, Site #127Philadelphia, Pennsylvania  19111
Medical University of South Carolina, Site #148Charleston, South Carolina  29425
Tennesse Oncology, PLLC, Site # 076Nashville, Tennessee  37203
Seattle Cancer Care Alliance, Site #100Seattle, Washington  98109