NCT01334996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2007

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2019

Completed
Last Updated

April 10, 2020

Status Verified

April 1, 2020

Enrollment Period

14.6 years

First QC Date

December 25, 2007

Last Update Submit

April 9, 2020

Conditions

Systemic Mastocytosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Stability or improvement in biochemical markers of systemic mastocytosis

    1 year

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with systemic mastocytosis having up to 20% bone marrow involvement or clinical symptoms not controlled on current medications.

You may qualify if:

  • Systemic Mastocytosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

MeSH Terms

Conditions

Mastocytosis, Systemic

Condition Hierarchy (Ancestors)

MastocytosisNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsMast Cell Activation DisordersImmune System Diseases

Study Officials

  • Joseph H Butterfield, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

December 25, 2007

First Posted

April 13, 2011

Study Start

February 1, 2005

Primary Completion

August 28, 2019

Study Completion

August 28, 2019

Last Updated

April 10, 2020

Record last verified: 2020-04

Locations

US(1)