Indolent systemic mastocytosis – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Tue, 16 Jun 2026 04:02:05 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Indolent systemic mastocytosis – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Study of Elenestinib for Patients with Indolent Systemic Mastocytosis https://clinicaltrials.eu/trial/study-of-elenestinib-for-patients-with-indolent-systemic-mastocytosis/ Wed, 29 Apr 2026 14:58:16 +0000 https://clinicaltrials.eu/trial/study-of-elenestinib-for-patients-with-indolent-systemic-mastocytosis/ This clinical trial is focused on studying a condition called Indolent Systemic Mastocytosis, which is a type of disease where certain cells in the body, known as mast cells, grow uncontrollably and cause various symptoms. The trial will test a new treatment called ELENESTINIB, also known by its code name BLU-263. This medication is taken as a film-coated tablet and is being studied to see if it can help manage the symptoms of this condition.

The purpose of the study is to determine the right dose of ELENESTINIB for treating Indolent Systemic Mastocytosis. Participants in the study will be randomly assigned to receive either the medication or a placebo, which looks like the medication but does not contain the active ingredient. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure the results are unbiased. The study will last for several weeks, during which participants will take the medication or placebo and have regular check-ups to monitor their health and any changes in their symptoms.

Throughout the study, the safety and tolerability of ELENESTINIB will be closely monitored by checking for any side effects or changes in health indicators like vital signs and laboratory test results. The effectiveness of the treatment will be assessed by measuring changes in symptoms and other health markers. The study aims to provide valuable information on whether ELENESTINIB can be a safe and effective treatment option for people with Indolent Systemic Mastocytosis.

]]> Study of TL-895 for Patients with Relapsed or Refractory Myelofibrosis or Indolent Systemic Mastocytosis https://clinicaltrials.eu/trial/study-of-tl-895-for-patients-with-relapsed-or-refractory-myelofibrosis-or-indolent-systemic-mastocytosis/ Wed, 29 Apr 2026 14:27:24 +0000 https://clinicaltrials.eu/trial/study-of-tl-895-for-patients-with-relapsed-or-refractory-myelofibrosis-or-indolent-systemic-mastocytosis/ This clinical trial is focused on studying the effects of a medication called TL-895 in individuals with certain blood-related conditions. The diseases being studied are Myelofibrosis and Indolent Systemic Mastocytosis. Myelofibrosis is a disorder where scar tissue forms in the bone marrow, affecting blood cell production. Indolent Systemic Mastocytosis is a condition where there is an abnormal accumulation of mast cells, a type of white blood cell, in various tissues. The medication TL-895 is taken orally in the form of a film-coated tablet.

The purpose of this study is to determine the appropriate dose and schedule for TL-895 in treating these conditions. Participants in the study will receive either the medication or a placebo. The study will be conducted over a period of time, during which participants will be monitored for changes in their symptoms and overall health. The study aims to find out if TL-895 can improve symptoms and reduce the size of the spleen in patients with Myelofibrosis, as well as assess changes in symptoms for those with Indolent Systemic Mastocytosis.

Throughout the study, participants will be regularly assessed to ensure their safety and to evaluate the effectiveness of the treatment. The study will help determine if TL-895 is a viable treatment option for these conditions and will provide valuable information on how best to use the medication in future treatments. The trial is expected to conclude by the end of 2025.

]]> Study of Avapritinib for Patients with Indolent Systemic Mastocytosis Not Adequately Managed by Standard Therapy https://clinicaltrials.eu/trial/study-of-avapritinib-for-patients-with-indolent-systemic-mastocytosis-not-adequately-managed-by-standard-therapy/ Wed, 29 Apr 2026 14:23:11 +0000 https://clinicaltrials.eu/trial/study-of-avapritinib-for-patients-with-indolent-systemic-mastocytosis-not-adequately-managed-by-standard-therapy/ This clinical trial is focused on studying a condition called Indolent Systemic Mastocytosis (ISM), which is a type of disease where certain cells in the body, known as mast cells, grow uncontrollably and cause various symptoms. The trial is testing a medication called Avapritinib, which is a type of drug known as a tyrosine kinase inhibitor. This medication is designed to target specific mutations in the KIT gene that are often found in patients with ISM. The study also involves the use of a placebo, which is a substance with no active medication, to compare the effects of Avapritinib.

The purpose of the study is to evaluate the safety and effectiveness of Avapritinib in patients with ISM whose symptoms are not adequately controlled with standard treatments. The study is divided into three parts. In the first part, the appropriate dose of Avapritinib will be determined. The second part will compare the change in symptoms from the start of the study to a specific point in time between those taking Avapritinib and those taking a placebo. The third part will assess the long-term safety and effectiveness of Avapritinib in these patients.

Participants in the study will take Avapritinib in the form of film-coated tablets, which are taken orally. The study will monitor changes in symptoms, the burden of mast cells in the body, and the overall quality of life of the participants. Safety will be closely monitored through regular assessments, including checking vital signs, conducting electrocardiograms (ECGs), and performing laboratory tests. The study aims to provide valuable information on how well Avapritinib works in managing ISM and its long-term safety for patients.

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