Use of Tamoxifen in Systemic Mastocytosis

Treatment of Systemic Mastocytosis With Tamoxifen

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01334996

Enrollment

Registered

2011-04-13

Start date

2005-02-28

Completion date

2019-08-28

Last updated

2020-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Mastocytosis

Brief 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.

Detailed description

Not desired

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* Systemic Mastocytosis

Exclusion criteria

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

Design outcomes

Primary

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

Measure	Time frame	Description
Stability or improvement in biochemical markers of systemic mastocytosis	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)

Countries

United States

Outcome results