Imatinib in KIT-negative Systemic Mastocytosis

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Virgen de la Salud
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

• Age older than 18 years.

• Diagnosis of systemic mastocytosis in the absence of c-kit mutation.

• ECOG ≤ 3.

• Signed informed consent.

Exclusion Criteria:

• Previous therapy with a tyrosin kinase inhibitor.

• Positive antibodies against HIV or active viral hepatitis.

• Impaired liver function (total bilirubin ≥ 2.0 mg/dl, AST or ALT > 3 x upper limit of normal).

• Impaired renal function (≥ 2.0 mg/dL).

• Grade III-IV cytopenias not related to mastocytosis.

• Severe cardiopathy (grade III/IV of NYHA, or left ventricular ejection fraction < 50%).

• Pregnancy or breastfeeding.

• Female patients who do not use contraceptive methods.