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Report for Clinical Trial NCT01602939

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT01602939 Systemic Mastocytosis
MeSH:Mastocytosis Mastocytosis, Systemic
HPO:Mastocytosis

1 Interventions

Name: Cladribine and pegylated interpheron alpha-2a

Description: 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.
Type: Drug
Group Labels: 1

2CDA+IFN


Primary Outcomes

Description: Evaluation of bone marrow response will be assessed by immunohistochemestry, citology, flow cytometry and molecular analyses of bone marrow samples.

Measure: To evaluate the effect of therapy on bone marrow mast cell infiltration.

Time: 6 months

Secondary Outcomes

Description: Serum tryptase and any other mastocytosis-related altered biochemical parameter at diagnosis will be measured monthly until the end of therapy.

Measure: To determine the effect of therapy on serum tryptase levels and other altered peripheral blood parameters due to mastocytosis.

Time: 6 months

Description: Specific questionnaires regarding mast cell-mediator release symptoms will be filled monthly by each patient until the end of therapy.

Measure: To evaluate the effect of therapy on mast cell-mediator release symptoms: pruritus, flushing, gastrointestinal symptoms or anaphylaxis).

Time: 6 months

Description: Potentially drugs-related adverse events will be recorded in each case following accepted criteria (NIH CTCAE).

Measure: To determine de safety of combined therapy with low doses of cladribine plus pegylated interpheron alpha-2a.

Time: 6 months

Description: Evaluation of cutaneous response will be assessed by macroscopic inspection including photographs and by skin immunohistochemestry.

Measure: To evaluate the effect of therapy on mastocytosis skin lesions.

Time: 6 moths

Description: Evaluation of organomegalies response will be assessed by abdominal ultrasound and/or computerized tomography.

Measure: To evaluate the effect of therapy on mastocytosis-related organomegalies.

Time: 6 months

Description: Evaluation of bone response will be assessed by X-ray survey and/or computerized tomography.

Measure: To evaluate the effect of therapy on mastocytosis-related bone alterations.

Time: 6 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 D816V

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

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

- Diagnosis of advanced systemic mastocytosis (aggressive systemic mastocytosis or proggressing systemic mastocytosis) with D816V or other exon 17 KIT mutations. --- D816V ---



HPO Nodes


HPO: