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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01334996
Other study ID # 2506-04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2005
Est. completion date August 28, 2019

Study information

Verified date April 2020
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, the investigators will determine the utility of Tamoxifen, a non-cytotoxic agent, to improve quality of life, biochemical parameters, and bone marrow involvement in systemic mastocytosis patients having 1) up to 40% bone marrow infiltration by mast cells and/or 2) mediator-release symptoms which are not controlled by tolerated doses of standard "non-cytotoxic" medications regardless of the percentage bone marrow involvement by mastocytosis. The dose of Tamoxifen will be 40 mg/day and the duration of treatment will be for one year. Patients currently taking interferon alfa, imatinib mesylate, or cladribine will be excluded until these medications have been stopped.


Description:

Not desired


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date August 28, 2019
Est. primary completion date August 28, 2019
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Systemic Mastocytosis

Exclusion Criteria:

- Current treatment with Imatinib mesylate, cladribine or interferon alpha.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stability or reduction of the percent bone marrow involvement by mastocytosis, including stable mast cell morphology and phenotype. up to 40% bone marrow infiltration by mast cells and/or 2) mediator-release symptoms which are not controlled by tolerated doses of standard "non-cytotoxic" medications regardless of the percentage bone marrow involvement by mastocytosis. The dose of Tamoxifen will be 40mg/day and the duration of treatment will be for one year. 1 year
Secondary Stability or improvement in biochemical markers of systemic mastocytosis Stability or improvement in biochemical markers of systemic mastocytosis (serum tryptase, calcitonin, urinary N-methyl histamine and prostaglandin F2 excretion/24 hours, liver function studies, lactic dehydrogenase, complete blood count with leukocyte differential) 1 year
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