AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance
NCT04174612 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172
Last updated 2022-03-02
Summary
Prospective, multi-center, interventional, randomized, open clinical trial for the treatment of acute myeloid leukemia with FLT3 mutations customized upon the prognostic parameter PBC
Conditions
- Acute Myeloid Leukemia With FLT3/ITD Mutation
Interventions
- DRUG
-
100 mg/m2/bid day 1-3 100 mg/m2/die day 4-7
- DRUG
-
Daunorubicin
60 mg/m2/die day 1-3
- DRUG
-
Midostaurin
50 mg/bid day 8-21
- DRUG
-
Cytarabine HD
100 mg/m2/bid day 1-3 100 mg/m2/die day 4 1.500 mg bid day 5-7
Sponsors & Collaborators
-
Gruppo Italiano Malattie EMatologiche dell'Adulto
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-04-24
- Primary Completion
- 2022-12-31
- Completion
- 2025-08-01
Countries
- Italy
Study Locations
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