Cladribine Plus Pegylated Interpheron Alfa-2a in Systemic Mastocytosis
NCT ID: NCT01602939
Last Updated: 2016-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
10 participants
INTERVENTIONAL
2012-05-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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2CDA+IFN
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Hospital Virgen de la Salud
OTHER
Responsible Party
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LUIS ESCRIBANO
Director of the Instituto de Estudios de Mastocitosis de Castilla La Mancha
Principal Investigators
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Luis Escribano, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Estudios de Mastocitosis de Castilla La Mancha
Locations
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Instituto de Estudios de Mastocitosis de Castilla La Mancha; Hospital Virgen del Valle
Toledo, Toledo, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EC11-187
Identifier Type: -
Identifier Source: org_study_id
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