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Midostaurin in MRD (Minimal Residual Disease) Positive Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation

NCT03951961 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-01-21

No results posted yet for this study

Summary

The MAURITIUS trial is a single-arm, multicenter phase II study of single treatment with midostaurin being applied to AML (acute myeloid leukemia) patients with activating FLT3 (FMS-like tyrosine kinase3) mutations and either molecular relapse or persistent molecular positivity after allogeneic SCT. The leukemia-free survival (LFS), the achievement of "MRD low" as well as the incidence of GvHD after transplantation reflect the most relevant endpoints of this non-randomized clinical trial.

Conditions

  • Acute Myeloid Leukemia, Adult

Interventions

DRUG

Midostaurin

50mg Midostaurin bid for 12 months

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • University of Jena

    lead OTHER

Principal Investigators

  • Sebastian Scholl, Prof. Dr. · Jena University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-20
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • Germany

Study Locations

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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 NCT03951961 on ClinicalTrials.gov