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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 - D2201
The purpose of this single arm, phase II, open-label study is to evaluate if a Novartis investigational drug taken orally twice daily is effective and safe in treating people with aggressive systemic mastocytosis or mast cell leukemia with or without an additional hematological neoplasm.
An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
Trial phase: Phase 2 Participation Duration: Participants will be given the investigational drug 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 |