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Midostaurin in Indolent Systemic Mastocytosis

NCT01920204 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-01-19

No results posted yet for this study

Summary

Rationale: Patients with indolent or smoldering systemic mastocytosis can have severe disabling symptoms. Almost all patients have fatigue, a compromised quality of life, hampering normal functioning. Because this form of mastocytosis is not considered life-threatening, mast cell eradication has never been applied and patients receive only symptomatic therapy with histamine blockers. Midostaurin, a c-KIT inhibitor has shown activity regarding symptom control and decrease of malignant mast cells in patients with aggressive systemic mastocytosis (ASM) or mast cell leukemia

Conditions

  • Indolent Systemic Mastocytosis

Interventions

DRUG

Midostaurin,

Midostaurin, twice daily 100 mg orally, continuously for 6 months

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • J.C. Kluin-Nelemans, MD, PhD · University Medical Center Groningen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-03-31
Completion
2015-05-31

Countries

  • Netherlands

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 NCT01920204 on ClinicalTrials.gov