Multicenter, Open-Label, Single Arm Phase II Clinical Trial of Dasatinib in the Treatment of Systemic Mastocytosis (SM) - Dasatinib and systemic mastocytosis

• Conditions: Systemic mastocytosis; MedDRA version: 9.1Level: LLTClassification code 10042949

• Registration Number: EUCTR2008-006183-11-IT
• Lead Sponsor: IVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-28
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) A diagnosis of systemic mastocytosis, according to the WHO criteria; 2) A classification of mastocytosis as either aggressive (presence of C-findings) or smouldering/indolent (presence of B-findings) with severe clinical signs or symptoms unresponsive to antimediator treatment; patients with mastocytosis associated with hematologic non mast cell disease (AHNMD) will be included if the two disorders need to be treated independently, as indicated by the Consensus Guidelines 3) Age >18 years old. Fertile men and women must agree to use a medically acceptable form of contraception during the study; 4) A preserved liver and kidney function as assessed by: a) total bilirubin not exceeding 2.0 times the institutional upper limit of normal (ULN); b) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) not exceeding 2.5 times ULN; c) serum creatinine not exceeding 2.0 times ULN.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Pregnancy or breast feeding; 2) Uncontrolled CNS involvement by mastocytosis or other medical disorder that would impair the ability of the subject to receive cytoreductive therapy; 3) Uncontrolled or active significant cardiovascular disease; 4) An altered mental status that would prevent understanding or rendering of informed consent; 5) Clinically significant bleeding from the GI tract within the last 2 months; 6) Current treatment with prednisone at dose >15 mg/day; 7) Current treatment with cytoreductive drug (IFN, 2-CdA or imatinib). Patients can be enrolled in the study if this treatment has been discontinued at least 1 month prior of enrollment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified