At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 126 enrolled
Drug / intervention
CPX-351 +1 moredrug
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.
Phase IIB, Multicenter, Randomized, Open-Label Trial Of CPX-351 (Cytarabine : Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adult Patients ≤ 65 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration
In Brief
A Phase 2 clinical trial evaluating CPX-351 and Intensive Salvage Therapy for Acute Myeloid Leukemia. Completed, enrolled 126 participants across 42 sites in 4 countries.
Detailed Summary
The study investigates if CPX-351 will be a) more effective than the standard intensive salvage AML treatment and b) more tolerable than the standard intensive salvage treatment regimens. The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesCanada, France, Poland, United States
CollaboratorsThe Leukemia and Lymphoma Society
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2009
Enrollment StartFeb 2009
Primary CompletionDec 2011
Study CompletionJan 2012
TodayJul 2026
First PostedJan 14, 2009
Enrollment StartFeb 1, 2009
Primary CompletionDec 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.5 years ago
Interventions
CPX-351drug
Intensive Salvage Therapydrug