Cladribine Plus Pegylated Interpheron Alfa-2a in Systemic Mastocytosis

• Status: Unknown status
• Trial end date: 2017-06-01
• 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 Cladribine plus Pegylated Interpheron alpha-2a therapy in patients with advanced systemic mastocytosis carrying D816V or other exon 17 KIT mutations.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Virgen de la Salud
• Treatments: Cladribine

Criteria

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.