AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance

NCT04174612 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2022-03-02

No results posted yet for this study

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

Cytarabine

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04174612 on ClinicalTrials.gov