At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 11 enrolled
Drug / intervention
liposomal cytarabine-daunorubicin CPX-351drug
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 Phase II Study of CPX-351 for Treatment of AML or Higher Risk MDS Relapsed or Refractory to Prior Therapy With Hypomethylating (HMA) Agent
In Brief
A Phase 2 clinical trial evaluating liposomal cytarabine-daunorubicin CPX-351 for Adult Acute Erythroid Leukemia (M6) and 15 related conditions. Completed, enrolled 11 participants across 1 site.
Detailed Summary
This phase 2 clinical trial studies how well CPX-351 (liposomal cytarabine-daunorubicin) works in treating patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome. Drugs used in chemotherapy, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Acute Erythroid Leukemia (M6), Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia and Acute Monocytic Leukemia (M5), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartFeb 2014
Primary CompletionDec 2017
Study CompletionDec 2017
TodayJul 2026
First PostedDec 24, 2013
Enrollment StartFeb 3, 2014
Primary CompletionDec 4, 2017
Study CompletionDec 18, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.5 years ago
Interventions
liposomal cytarabine-daunorubicin CPX-351drug
Given IV