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OpenTrials
Completed

NCT Number: NCT01334996

Use of Tamoxifen in Systemic Mastocytosis

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.

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Key information

Conditions

Systemic Mastocytosis Immune System Diseases Mast Cell Activation Disorders Mastocytosis Mastocytosis, Systemic Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55901, United States

About this study

Not desired

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Systemic Mastocytosis

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Stability or reduction of the percent bone marrow involvement by mastocytosis, including stable mast cell morphology and phenotype.

    Time frame: 1 year

    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.

Secondary outcomes

  1. Stability or improvement in biochemical markers of systemic mastocytosis

    Time frame: 1 year

    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)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Treatment of Systemic Mastocytosis With Tamoxifen

Important dates

Study start
2005
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2011
Registry last updated
Apr 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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