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CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics

Study acronym: ALFA2101
StatusRecruiting
PhasePhase 2
Started2023-05-03
View on ClinicalTrials.gov ↗

Amendment history

2026-03-24
Study Status, Study Description, Study Design, Arms and Interventions, Contacts/Locations v5
Primary completion date2027-10→2028-08-02
Completion date2027-10→2030-02-02
Enrollment target210→248
Study sites30→35
Study description-320 characters
[...] ition,P-gp activity will be explore as a putative biomarker. Duration of the enrollment period: 36 months Duration of treatment: 6 months Duration of the participation for a patient: 18 months (post randomization) (including approximately 6 months treatment, and 12 months of post-treatment follow up) Overall duration of the study: 58 months including the ana [...]
2024-01-29
Study Status, Contacts/Locations v4
Study sitesdetails revised at 4 of 30 sites
2023-07-10
Study Status, Contacts/Locations v3
Study sitesdetails revised at 20 of 30 sites
2023-05-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-10→2027-10
Completion date2026-10→2027-10
Start dateestimated 2022-04→confirmed 2023-05-03
Study sitesdetails revised at 30 of 30 sites
2022-04-08
Study Status, Contacts/Locations v1
Study sites1→30
2022-02-17
Original filing
The trial is a randomized, open-label phase II study comparing CPX-351 vs conventional intensivechemotherapy in patients with newly diagnosed de novo AML and intermediate- or adverse-risk genetics
Trial Details
NCT Number NCT05260528
Lead Sponsor Centre Hospitalier Universitaire de Nice
Collaborators: Jazz Pharmaceuticals, Acute Leukemia French Association
Conditions Acute Myeloid Leukemia
Enrollment 248 participants
Start Date 2023-05-03
Primary Completion 2028-08-02 (estimated)
Study Completion 2030-02-02 (estimated)
Updated on ClinicalTrials.gov 2026-03-27