Imatinib in KIT-negative Systemic Mastocytosis
NCT01297777 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2016-08-29
Summary
The aim of this study is to evaluate the efficacy in terms of clinical and biological response rates of Imatinib Mesylate therapy in patients with systemic mastocytosis lacking KIT mutations.
Conditions
Interventions
- DRUG
-
Imatinib Mesylate
* In patients without B or C findings and without biological progression: 300 mg/24 h p.o during one year or until progression/unacceptable toxicity. * In patients with B or C findings or biological progression: 300 mg/24 h p.o for two weeks and then 400 mg/24 h p.o for a total of one year of therapy, or until progression/unacceptable toxicity.
Sponsors & Collaborators
-
Hospital Virgen de la Salud
lead OTHER
Principal Investigators
-
Luis Escribano, MD, PhD · Instituto de Estudios de Mastocitosis de Castilla La Mancha
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2015-08-31
- Completion
- 2015-08-31
Countries
- Spain
Study Locations
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