NCT03335267

Investigator Initiated Trial of CPX-351 for Untreated Acute Myeloid Leukemia

Phase II Trial of CPX (Cytarabine:Daunorubicin) Liposome Injection in Patients >/=60 Years of Age With AML Previously Untreated By Intensive Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This is an open label study to assess the suitability of CPX-351 as first intensive therapy in elderly (age ≥60 years) patients with AML. Patients may have received prior AML treatment with non-intensive regimens, e.g. hypomethylating agents, low dose Ara C or lenolidomide, but may not have received intensive AML treatment with anthracyclines and/or cytarabine prior to enrollment on this trial. The outcome of elderly patients following intensive treatment with CPX-351 will be measured by clinical endpoints for efficacy and safety and by biological/functional response.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
DRUG	CPX-351	Cytarabine:Daunorubicin Liposome Injection

Timeline

• Start date: 2017-10-19
• Primary completion: 2018-12-19
• Completion: 2020-05-29
• First posted: 2017-11-07
• Last updated: 2024-02-22
• Results posted: 2024-02-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study