Know Cancer

or
forgot password

Treatment Plan for the Compassionate Use of Ponatinib (AP24534) in Patients With Imatinib-, Dasatinib-, and Nilotinib- Resistant/Intolerant Philadelphia Chromosome Positive Leukemias.


N/A
18 Years
N/A
Not Enrolling
Both
Philadelphia Chromosome Positive (Ph+) Leukemias, Chronic Myeloid Leukemia

Thank you

Trial Information

Treatment Plan for the Compassionate Use of Ponatinib (AP24534) in Patients With Imatinib-, Dasatinib-, and Nilotinib- Resistant/Intolerant Philadelphia Chromosome Positive Leukemias.


Inclusion Criteria:



- Signed and dated informed consent

- Cytogenetic or PCR-based diagnosis of any phase of Ph+ acute lymphoblastic leukemia
(ALL) and documented resistance or intolerance to imatinib and a second TKI
(nilotinib, dasatinib, bosutinib)

- Eastern Cooperative Oncology Group(ECOG) performance status of 0-2

- Washout from prior anti-proliferative or anti-leukemia treatment: 3 days for
hydroxyurea/anagrelide and tyrosine kinase inhibitors

- < Grade 2 or baseline recovery from prior therapy related toxicities (except
alopecia)

- At least 3 months post allogeneic stem cell transplantation

- Able to take oral capsules reliably

- AST/ALT less than or equal to 2.5 times ULN, or less than 5 times ULN if attributable
to involvement of leukemia

- No active clinical or radiographic pancreatitis

- At least 18 years of age

- Willingness of male and female subjects to use reliable methods of birth control
(when applicable)

Exclusion Criteria:

- Subjects with Philadelphia Chromosome and BCR-ABL-negative chronic myeloid leukemia
(CML)

- Major surgery or radiotherapy within 7 days before the first dose of Ponatinib
(recovery from any previous surgery should be complete before day 1)

- Clinically significant active/uncompensated or uncontrolled cardiac disease (active
congestive heart failure; uncontrolled angina or hypertension; myocardial infarction
in the past 3 months; clinically significant untreated ventricular arrhythmia;
diagnosed or suspected congenital or acquired prolonged QT syndrome; unexplained
syncope; history of prolonged QTc)

- Prolonged QTc (> 0.48 sec)

- Pregnant or breastfeeding women

- Evidence of serious active infection, or significant medical or psychiatric illness

- Known seropositivity to HIV, or current acute or chronic Hepatitis B or Hepatitis C
(antigen positive), cirrhosis, or clinically significant abnormal lab finding that
would, in the investigator's judgment, make the subject inappropriate for this study

- Prior resistance to Ponatinib

Type of Study:

Expanded Access

Study Design:

N/A

Authority:

United States: Food and Drug Administration

Study ID:

IRB00008238

NCT ID:

NCT01549548

Start Date:

Completion Date:

Related Keywords:

  • Philadelphia Chromosome Positive (Ph+) Leukemias
  • Chronic Myeloid Leukemia
  • CML
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

Name

Location

OHSU Knight Cancer InstitutePortland, Oregon  97239