Cladribine Plus Pegylated Interpheron Alfa-2a in Systemic Mastocytosis
Cladribine Plus Pegylated Interpheron Alfa-2a in Systemic Mastocytosis
The aim of this study is to evaluate the efficacy in terms of clinical and biological
 response rates of Cladribine plus Pegylated Interpheron alpha-2a therapy in patients with
 advanced systemic mastocytosis carrying D816V or other exon 17 KIT mutations.
Inclusion Criteria:

 -  Age older than 18 years.

 -  Diagnosis of advanced systemic mastocytosis (aggressive systemic mastocytosis or
 proggressing systemic mastocytosis) with D816V or other exon 17 KIT mutations.

 -  ECOG ≤ 3.

 -  Signed informed consent.

 Exclusion Criteria:

 -  Impaired liver function (total bilirubin ≥ 2.0 mg/dl, AST or ALT > 3 x upper limit of
 normal)not related to mastocytosis.

 -  Impaired renal function (≥ 2.0 mg/dL)not related to mastocytosis.

 -  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.