Use of Tamoxifen in Systemic Mastocytosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01334996|
Recruitment Status : Unknown
Verified August 2014 by Mayo Clinic.
Recruitment status was: Recruiting
First Posted : April 13, 2011
Last Update Posted : August 12, 2014
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||6 participants|
|Official Title:||Treatment of Systemic Mastocytosis With Tamoxifen|
|Study Start Date :||February 2005|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
- 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 20 mg/day and the duration of treatment will be for one year.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334996
|Contact: Joseph H Butterfield, MDfirstname.lastname@example.org|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55901|
|Contact: Joseph H Butterfield, MD 507-284-3783 email@example.com|
|Principal Investigator:||Joseph H Butterfield, MD||Mayo Clinic|