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


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Advanced Systemic Mastocytosis

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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

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