Trial Information
Subcutaneous Cladribine Plus Pegylated Interpheron Alfa-2a in Advanced Systemic Mastocytosis With D816V and 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the effect of therapy on bone marrow mast cell infiltration.
Outcome Description:
Evaluation of bone marrow response will be assessed by immunohistochemestry, citology, flow cytometry and molecular analyses of bone marrow samples.
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Luis Escribano, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Instituto de Estudios de Mastocitosis de Castilla La Mancha
Authority:
Spain: Ministry of Health
Study ID:
EC11-187
NCT ID:
NCT01602939
Start Date:
May 2012
Completion Date:
May 2013
Related Keywords:
- Advanced Systemic Mastocytosis
- Mast cell
- Mastocytosis
- Mast cell disease
- Mastocytosis
- Urticaria Pigmentosa
- Mastocytoma
- Mastocytosis, Systemic