NCT01602939

Cladribine Plus Pegylated Interpheron Alfa-2a in Systemic Mastocytosis

Subcutaneous Cladribine Plus Pegylated Interpheron Alfa-2a in Advanced Systemic Mastocytosis With D816V and Other Exon 17 KIT Mutations.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Hospital Virgen de la Salud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Mastocytosis

Interventions

Type	Name	Description
DRUG	Cladribine and pegylated interpheron alpha-2a	Cladribine (0.07 mg/Kg/day) s.c for 5 consecutive days each month for a total of 6 months.Cladribine daily doses could be increased up to 0.14 mg/Kg in the fourth, fifth and sixth cycles of therapy if no objetive response is achieved after the third cycle. Pegylated Interpheron alpha-2a (1 mcgr/Kg) s.c weekly for a total of 6 months.

Timeline

• Start date: 2012-05-01
• Primary completion: 2017-02-01
• Completion: 2017-06-01
• First posted: 2012-05-21
• Last updated: 2016-08-29

Locations

1 site across 1 country: Spain