CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
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.

Search/NCT03335267
NCT03335267Phase 2Completed
CompareCT.gov

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

Weill Medical College of Cornell University·interventional·Posted Nov 7, 2017·Updated Feb 22, 2024

In Brief

A Phase 2 clinical trial evaluating CPX-351 for Leukemia, Myeloid, Acute. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myeloid, Acute
CountriesUnited States
CollaboratorsJazz Pharmaceuticals

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 7, 2017
Enrollment StartOct 19, 2017
Primary CompletionDec 19, 2018
Study CompletionMay 29, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.7 years ago

Interventions

CPX-351drug

Cytarabine:Daunorubicin Liposome Injection