A Pivotal Phase 2 Trial of Ponatinib (AP24534) in Patients With Refractory Chronic Myeloid Leukemia and Ph+ Acute Lymphoblastic Leukemia
The preliminary analysis of the phase 1 clinical trial revealed evidence of clinical
antitumor activity in patients with resistance to approved second-generation tyrosine kinase
inhibitors (TKI), dasatinib and nilotinib, including patients with the T315I mutation of
BCR-ABL. This study, taken together with the strong preclinical data that characterize
ponatinib, provides the rationale for moving to a pivotal phase 2 trial of this agent in a
population of patients with chronic myeloid leukemia (CML) and Ph+ Acute Lymphoblastic
Leukemia (ALL) who are resistant or intolerant to prior TKI therapy and in those patients
with the T315I mutation.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Major cytogenetic response (MCyR) CP patients, and Major Hematologic Response (MaHR) AP/BP and Ph+ ALL patients
For CML patients in CP at study entry: major cytogenetic response (MCyR), defined as complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CP patients in CCyR are not eligible for this study. For CML patients in AP at study entry: major hematologic response (MaHR), defined as complete hematologic response (CHR) or no evidence of leukemia (NEL). AP patients in MaHR are not eligible for this study. For CML patients in BP at study entry or Ph+ ALL patients: MaHR, consisting of CHR or NEL. BP and Ph+ ALL patients in MaHR are not eligible for this study.
up to 24 months after first dose
No
United States: Food and Drug Administration
AP24534-10-201
NCT01207440
September 2010
October 2020
Name | Location |
---|---|
UCLA Ronald Reagan Medical Center, Site #027 | Los Angeles, California 90095 |
H. Lee Moffitt Cancer Center & Research Institute, Site #017 | Tampa, Florida 33612 |
Emory Winship Cancer Institute, Site # 058 | Atlanta, Georgia 30322 |
The University of Chicago, Site # 001 | Chicago, Illinois 60637 |
Northwestern University Feinberg School of Medicine, Site # 023 | Chicago, Illinois 60611 |
University of Maryland, Greenebaum Cancer Center, Site # 040 | Baltimore, Maryland 21201 |
Dana-Farber Cancer Institute , Site # 008 | Boston, Massachusetts 02115 |
University of Michigan Medical Center, Site # 011 | Ann Arbor, Michigan 48109 |
Karmanos Cancer Institute, Site # 034 | Detroit, Michigan 48201 |
Washington University School of Medicine, Site # 007 | St. Louis, Missouri 63110-1093 |
Nebraska Hematology-Oncology, PC, Site #133 | Lincoln, Nebraska 68506 |
Northern New Jersey Cancer Associates, Site #128 | Hackensack, New Jersey 07601 |
Roswell Park Cancer Institute, Site #029 | Buffalo, New York 14263 |
Weill Medical College of Cornell University, Site #006 | New York, New York 10065 |
Memorial Sloan-Kettering Cancer Center, Site #078 | New York, New York 10065 |
Duke University Medical Center, Site #003 | Durham, North Carolina 27710 |
Oregon Health and Sciences University, Site #048 | Portland, Oregon 97239-3098 |
Jeanes Hospital of Temple University Health System, Site # 127 | Philadelphia, Pennsylvania 19111 |
MD Anderson Cancer Center, Site # 005 | Houston, Texas 77030 |
Huntsman Cancer Institute at the University of Utah, Site #043 | Salt Lake City, Utah 84112 |
Fred Hutchinson Cancer Research Center, Site #100 | Seattle, Washington 98109 |