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Novartis Clinical
Trials provides information about research studies recruiting
within the U.S. Visit ClinicalTrials.gov, a registry of federally and privately supported clinical trial for more information regarding clinical trials outside of the U.S. |
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Systemic Mastocytosis/ Mast Cell Leukemia
Systemic Mastocytosis is a rare disease in which too many mast cells (a type of immune system cell) are found in the skin, bones, joints, lymph nodes, liver, spleen, and gastrointestinal tract. Mast cells give off chemicals such as histamine that can cause flushing (a hot, red face), itching, abdominal cramps, muscle pain, nausea, vomiting, diarrhea, low blood pressure, and shock. Mast cell leukemia (MCL) is an extremely rare form of mastocytosis where more than 20% of cells in bone marrow are mast cells, in addition to signs of organ dysfunction. [Source: www.cancer.gov]
Novartis is seeking people to participate in a clinical trial(s) testing the safety and effectiveness of Novartis products. Novartis recommends that you consult your doctor before participating in a clinical trial. For more information about clinical trial participation, click here. Also, for additional information about how Novartis helps to protect the privacy of the personal information that you provide to us, please see the Novartis Privacy Policy. Please review the details of the clinical trial(s) listed below and click on the one that you feel best suits your (or the participant's) condition.
Aggressive Systemic Mastocytosis (ASM) and Mast Cell Leukemia (MCL) Study CPKC412D2201
The purpose of this clinical research is to determine if a Novartis investigational drug is a safe and effective treatment for people who have either aggressive systemic mastocytosis (ASM) or mast cell leukemia (MCL). An “investigational drug” is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).
Trial phase: Phase 2 Participation Duration: Participants will be given the study drug midostaurin (PKC412) in soft gelatin capsules and will be asked to take 4 capsules two times a day for twelve cycles. Each cycle consist of 28 days. Protocol Number: CPKC412D2201 |