AAML1831. A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
Categories (click each to see list of all clinical trials associated with that category): Pediatric (PEDONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Beck, Jill
Contact Information:
Angie Boettner
aboettner@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04293562?term=NCT04293562&rank=1
Summary
Primary Outcome Measures.
Event-free survival (EFS) [ Time Frame: Up to 3 years ]
The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death.
Secondary Outcome Measures :
Overall survival (OS) [ Time Frame: Up to 3 years ]
The Kaplan-Meier method will be used to estimate 3-year OS, defined as the time from study entry until death.
Proportion of patients positive for minimal residual disease (MRD+) [ Time Frame: Up to 4 weeks ]
The proportion of patients MRD+ at end of induction 1 (EOI1) will be estimated as the number of patients MRD+ divided by the number of patients with evaluable EOI1 MRD results along with a corresponding 95% confidence interval determined using a binomial exact method.
Proportion of patients who died during protocol therapy [ Time Frame: Up to 2 years ]
The proportion of patients who died during protocol therapy will be estimated along with the corresponding 95% confidence interval determined using a binomial exact method.
Relapse rate [ Time Frame: Up to 3 years ]
Cumulative incidence estimates will be used to determine the 3 year relapse rate defined as time from study entry to induction failure or relapse where deaths or secondary malignancies are competing events.
Treatment-related mortality rate (TRM) [ Time Frame: Up to 3 years ]
Cumulative incidence estimates will be used to determine the 3 year TRM defined as time from study entry to death where induction failure, relapse or secondary malignancies are competing events.
Incidence of adverse events [ Time Frame: Up to 2 years ]
The proportion of patients experiencing at least one grade 3 or higher non-hematologic toxicity and infection while on protocol therapy will be estimated along with the corresponding 95% confidence interval determined using a binomial exact method. Toxicity will be assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).