Clinical Trial

Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics

Active, Not Recruiting Phase 3
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Summary
The trial is a randomized, open-label phase III study comparing CPX-351 vs conventional intensive induction and consolidation chemotherapy in patients with newly diagnosed AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria), including AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML according to the World Health Organization (WHO) classification. Overall survival (OS) in the restricted set of de novo patients will be the primary endpoint.
Protocol Amendment History 66 amendments
This ClinicalTrials.gov record has been amended 66 times since 2019-03-28; most recent amendment 2025-07-14.
Status change: Recruiting → Active, Not Recruiting 2025-07-03
Status change: Not Yet Recruiting → Recruiting 2019-08-20
Trial Details
NCT Number NCT03897127
Lead Sponsor University of Ulm
Collaborators: Jazz Pharmaceuticals
Conditions Acute Myeloid Leukemia
Enrollment 882 participants
Start Date 2019-09-04
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2025-07-17