A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
FLT3-mutated Acute Myeloid Leukemia
No strong warning signs right now. The score counts warning signs; it is not a prediction.
Why this score
No warning signs right now. That's why the score is 0.
Score over time
- Stage
- Phase 2
- Patients
- 22 (final count)
- Started
- Mar 13, 2019
- Main results expected
- May 18, 2029
- Fully finished
- May 18, 2029
- Results posted
- not yet
What counts as success
The trial's main goal(s), called the “primary outcome.”
Part 1 of the study: Occurence of dose limiting toxicities (DLT)
Measured over: From the start of midostaurin treatment in Block 1 to the end of Block 2, from Day 1 to Day 84
Part 2 of the study: To evaluate Safety of midostaurin (30mg/m2 bid or 1 mg/kg bid for participants <10 kg body weight) in sequential combination with chemotherapy followed by 12 cycles of midostaurin post-consolidation therapy.
Measured over: From the start of treatment up to 5 years follow-up of last patient
Part 2 of the study: To evaluate Tolerability of midostaurin (30mg/m2 bid or 1 mg/kg bid for participants <10 kg body weight) in sequential combination with chemotherapy followed by 12 cycles of midostaurin post-consolidation therapy.
Measured over: From the start of treatment up to 5 years follow-up of last patient
Changes Tremor has spotted
Show details (technical version)
Score inputs
- none
Raw record changes
- none yet
Trial ID NCT03591510 · record last updated 2026-07-09 · checked 2026-11-09 15:47 UTC