April 29, 2015
Below are current clinical trials.3 studies in Systemic mastocytosis
(open studies only).
Filter this list of studies by location, status and more.
This is a non-randomized open label multi-center study. Patients with high-risk myeloproliferative neoplasms (systemic mastocytosis [SM], advanced symptomatic hypereosinoophic disorder [PED], myelofibrosis [MF], and chronic myelomonocytic leukemia [CMML]) will be treated with SL-401, which will be administered as a brief intravenous infusion for 3 consecutive days initially every 21 days for 4 cycles; every 28 days for cycles 5-7; then every 42 days. Stage 1 will consist of a period in which several doses of SL-401 are evaluated. The Stage 2 portion will enroll up to 18 patients with each of the 4 myeloproliferative malignancies: SM, PED, MF, and CMML. In entirety, the Stage 2 portion will consist of up to 72 patients who will be treated at a maximum tolerated dose or maximum tested dose in which multiple dose-limiting toxicities are not observed (identified in Stage 1).
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 20% 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. Patients currently taking interferon alfa, imatinib mesylate, or cladribine will be excluded until these medications have been stopped.
Measurement of urinary arachidonic acid metabolites such as prostaglandins PGD2, PGE2, 8-isoprostane and TBXB2 in mastocytosis.
Comparison of these novel markers to conventional markers of tryptase and the well characterized n-methyl histamine and 11β-prostaglandinF2α
- Butterfield JH (expert opinion). Mayo Clinic, Rochester, Minn. March 2, 2015.
- Pardanani A. Systemic mastocytosis in adults: 2013 update on diagnosis, risk stratification, and management. American Journal of Hematology. 2013;88:613.
- Systemic mastocytosis. American Academy of Allergy, Asthma and Immunology. http://www.aaaai.org/conditions-and-treatments/related-conditions/systemic-mastocytosis.aspx. Accessed Feb. 12, 2015.
- Mastocytosis explained. The Mastocytosis Society, Inc. http://tmsforacure.org/patients/mastocytosis_explained_2.php. Accessed Feb. 12, 2015.
- Akin C, et al. Diagnosis and classification of mastocytosis. Immunology and Allergy Clinics of North America. 2014;34:207.
- Siebenhaar F, et al. Treatment strategies in mastocytosis. Immunology and Allergy Clinics of North America. 2014;34:433.
- Golden AK. Decision Support System. Mayo Clinic, Rochester, Minn. Feb.17, 2015.
- Weiler CR (expert opinion). Mayo Clinic, Rochester, Minn. March 12, 2015.