Acute myeloid leukemia
Conditions
Brief summary
The primary endpoint of the trial will be proportion of event-free patients after 24 weeks of combination treatment (i.e. after up to 6 cycles of AZA for 7 d Q4W and up to 8 PEM infusions Q3W). Events are defined as: (i) First hematologic relapse after start of combined therapy, (ii) Death from any cause, (iii) AML-treatment other than PEM and AZA or HMA only.
Detailed description
Overall survival., Proportion of event-free patients after 12 weeks of combined therapy, Treatment-related mortality during 24 weeks of combined therapy, Course of MRD-burden measured as quantitative NPM1/ABL ratio over time
Interventions
DRUGAZACITIDINE
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Technische Universitaet Dresden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the trial will be proportion of event-free patients after 24 weeks of combination treatment (i.e. after up to 6 cycles of AZA for 7 d Q4W and up to 8 PEM infusions Q3W). Events are defined as: (i) First hematologic relapse after start of combined therapy, (ii) Death from any cause, (iii) AML-treatment other than PEM and AZA or HMA only. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival., Proportion of event-free patients after 12 weeks of combined therapy, Treatment-related mortality during 24 weeks of combined therapy, Course of MRD-burden measured as quantitative NPM1/ABL ratio over time | — |
Countries
Germany
Outcome results
None listed