Multicenter, International, Phase 3, 2-arm, open-label trial on Ponatinib compared to Imatinib in newly diagnosed CP-CML patients
ID Number 13-1220Principal Investigator(s)
John O. Mascarenhas
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to evaluate ponatinib as a potential treatment for patients who have been newly diagnosed with CML. Ponatinib is an experimental anti-cancer drug. Laboratory studies and animal research suggest that ponatinib stops cancer cells from growing by affecting different kinds of proteins in cancer cells. In particular, laboratory studies suggest that ponatinib may be effective in stopping a protein called breakpoint cluster region-abelson (BCR-ABL) which is important in CML. Ponatinib is made by ARIAD Pharmaceuticals, Inc., the study Sponsor.
Ponatinib has been evaluated in two clinical trials in patients with advanced CML and Philadelphia positive acute lymphocytic leukemia (Ph+ALL) where other standard treatments did not work or were no longer working for their condition. Based on the results observed in these studies, ponatinibmay be effective in treating patients who have been newly diagnosed with CML. Ponatinib is being studied as a possible cancer treatment and received accelerated approval by the United States Food and Drug Administration for the treatment of patients withCML and Ph+ ALL who are resistant or intolerant to prior tyrosine kinase inhibitor therapy.
This study will compare the effects of ponatinib to another drug called imatinib. Imatinib is approved by the United States Food and Drug Administration (FDA) and many other worldwide regulatory agencies for treating a variety of human cancers including newly diagnosed adult and pediatric patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in the chronic phase.
Recruiting Patients: Yes