At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 449 enrolled
Drug / intervention
Ponatinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pivotal Phase 2 Trial of Ponatinib (AP24534) in Patients With Refractory Chronic Myeloid Leukemia and Ph+ Acute Lymphoblastic Leukemia
In Brief
A Phase 2 clinical trial evaluating Ponatinib for Chronic Myeloid Leukemia and Ph+ Acute Lymphoblastic Leukemia. Completed, enrolled 449 participants across 42 sites in 11 countries.
Detailed Summary
The purpose of this study is to determine the efficacy of ponatinib in patients with chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or intolerant to either dasatinib or nilotinib, or have the (T)hreonine-315-(I)soleucine (T315I) mutation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, France, Germany, Italy, Netherlands, Singapore, South Korea, Spain, Sweden, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartSep 2010
Primary CompletionDec 2018
Study CompletionJan 2019
TodayJul 2026
First PostedSep 23, 2010
Enrollment StartSep 30, 2010
Primary CompletionDec 20, 2018
Study CompletionJan 17, 2019
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 15.8 years ago
Interventions
Ponatinibdrug
Ponatinib tablets.