Clinical trials: Mast Cell Disorder, open to volunteers
Systemic Mastocytosis
New Italian Mastocytosis Registry
This study will involve 27 centers in Italy. Since this is a multidisciplinary disease, participating centers may be from various medical areas (hematology, dermatology, allergy, etc.). The study will last 10 years.
- Trial name
- NIMR (NCT07917156)
- Testing
- CLINICAL AND BIOLOGICAL DATA COLLECTION
- Where
- 10 sites in Italy
- Volunteers
- 1,500 people
- Sponsor
- Associazione Rete Italiana Mastocitosi
Food Allergy in Children, Milk Allergy
Comparison Between a Rush and a Conventional Oral Immunotherapy Protocol to Treat Cow's Milk and Hen´s Egg Allergy. CompITO Study
This study investigates the efficacy and safety of two different OIT schemes to treat milk and egg allergic children
- Conditions
- Food Allergy in Children, Milk Allergy, Egg Allergy
- Trial name
- compITO (NCT06976775)
- Testing
- "Rush" regimen, "Conventional" regimen
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- Pablo Rodríguez del Rio
Chronic Myeloproliferative Disorders, Leukemia
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
RATIONALE: Collecting and storing samples of tissue, blood, and body fluid from patients with cancer to study in the laboratory may help the study of cancer in the future.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder
- Trial name
- NCT01137643
- Testing
- biologic sample preservation procedure, cytology specimen collection procedure
- Where
- United States
- Volunteers
- 15,000 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Indolent Systemic Mastocytosis
An Observational Study in Participants With Indolent Systemic Mastocytosis (ISM)
This is a Phase 4, non-interventional, observational study to collect detailed data on the clinical characteristics, clinical outcomes and medical management of ISM in real-world settings.
- Trial name
- NCT07264959
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- Blueprint Medicines Corporation
Acute Biphenotypic Leukemia, Acute Leukemia
Depletion of CD45RA Positive Naive T Cells for the Prevention of Graft Versus Host Disease in Older Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Acute Leukemia or Myelodysplastic Syndrome
This phase II trial tests how well removing CD45RA positive naive T cells works to prevent graft versus host disease in older patients undergoing standard of care allogeneic hematopoietic stem cell transplantation for the…
- Conditions
- Acute Biphenotypic Leukemia, Acute Leukemia, Acute Leukemia of Ambiguous Lineage, Acute Lymphoblastic Leukemia
- Trial name
- NCT07819396
- Testing
- Allogeneic CD34+-enriched and CD45RA-depleted PBSCs, Biospecimen Collection, Bone Marrow Aspiration
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Fred Hutchinson Cancer Center
Anaphylaxis, Mastocytosis
Analysis of the Role of IgE Proteoforms in Health and Disease
The goal of this observational study is to evaluate the role of IgE proteoforms in healthy volunteers and in patients with type I allergy, patients with chronic spontaneous urticaria, patients with a recent history of…
- Conditions
- Anaphylaxis, Mastocytosis, X-linked Agammaglobulinaemia, Venom Allergy
- Trial name
- IgE-PhD (NCT07328178)
- Testing
- Blood sample collection
- Where
- Belgium
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- KU Leuven
Indolent Systemic Mastocytosis
A Non-Interventional Study in Participants With Indolent Systemic Mastocytosis (ISM) in Germany
This is a non-interventional study assessing the effectiveness of avapritinib (BLU-285) in the management of ISM in real-world settings in Germany.
- Trial name
- NCT07255638
- Testing
- Avapritinib
- Where
- 12 sites in Germany
- Volunteers
- 80 people
- Sponsor
- Blueprint Medicines Corporation
Indolent Systemic Mastocytosis, Smoldering Systemic Mastocytosis
(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis
This is a randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the efficacy and safety of elenestinib (BLU-263) + symptom directed therapy (SDT) with placebo + SDT in participants with indolent systemic…
- Trial name
- NCT04910685
- Testing
- Elenestinib
- Where
- 88 sites in United States, Argentina and 23 more
- Volunteers
- 534 people
- Sponsor
- Blueprint Medicines Corporation
Systemic Mastocytosis, KIT-D816V Mutation
Peripheral Blood KIT-D816V Mutation in Adult Systemic Mastocytosis
This observational study aims to evaluate the diagnostic value and clinical utility of detecting the KIT-D816V mutation in the peripheral blood of adult patients with systemic mastocytosis (SM), using droplet digital PCR (ddPCR).
- Trial name
- PB-KIT in SM (NCT07562542)
- Where
- China
- Volunteers
- 50 people
- Sponsor
- The First Affiliated Hospital of Soochow University
Healthy Subjects, Cold Urticaria
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
This is a first-in-human study aimed at determining the safety of a single dose of GTX-B001 in healthy participants and in people with chronic inducible urticaria.
- Conditions
- Healthy Subjects, Cold Urticaria, Symptomatic Dermographism, Chronic Inducible Urticaria
- Trial name
- CHILL-MC (NCT07181369)
- Testing
- GTX-B001, Normal Saline
- Where
- 5 sites in Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Granular Therapeutics Limited
Mastocytosis, Systemic
Avapritinib Rollover Study
The primary objective of the rollover study is to evaluate the long-term safety of avapritinib in participants who have completed a Blueprint Medicines sponsored study (parent study) and continued to benefit from avapritinib.
- Trial name
- NCT06748001
- Testing
- Avapritinib
- Where
- 7 sites in Belgium, Canada and 4 more
- Volunteers
- 60 people
- Sponsor
- Blueprint Medicines Corporation
Cutaneous Mastocytosis, Systemic Mastocytosis
Mastocytosis From Pediatric Age to Adulthood: Local Registry of Cutaneous and Systemic Mastocytosis
Given the renewed focus on mastocytosis (recognized in Italy as a rare disease since 2018) and emerging clinical and immunogenetic knowledge, and considering the rarity of the disease and limited understanding of its progression…
- Trial name
- MaRe (NCT07142473)
- Where
- Italy
- Volunteers
- 600 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Primary Myelofibrosis, Polycythemia Vera
Myeloproliferative Neoplasms (MPNs) Patient Registry
The mandate of this MPN registry is to collect clinical information, including molecular results, from consenting patients with a variety of MPNs at different time points during the course of their disease.
- Conditions
- Primary Myelofibrosis, Polycythemia Vera, Essential Thrombocythemia, Mastocytosis
- Trial name
- NCT02760238
- Testing
- Observational
- Where
- Canada
- Volunteers
- 5,000 people
- Sponsor
- University Health Network, Toronto
Alzheimer Disease
Masitinib in Patients With Mild Alzheimer's Disease
Masitinib is an orally administered tyrosine kinase inhibitor that targets activated cells of the neuroimmune system (mast cells and microglia).
- Trial name
- NCT05564169
- Testing
- Masitinib (4.5), Standard of care
- Where
- 9 sites in France, Spain
- Volunteers
- 600 people
- Sponsor
- AB Science
Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN)
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm…
- Conditions
- Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN), Mast Cell Leukemia (MCL), Aggressive Systemic Mastocytosis (ASM)
- Trial name
- NCT04996875
- Testing
- bezuclastinib
- Where
- 42 sites in United States, Australia and 12 more
- Volunteers
- 140 people
- Sponsor
- Cogent Biosciences, Inc.
Mastocytosis, Hypertryptasemia
Mastocytosis Registry (of Zurich)
The study aims to summarize patients with mastocytosis and hypertryptasämia (without underlying mastocytosis or no bone marrow biopsy) in relation to demographic information, clinical progress and treatment courses.
- Trial name
- MastoR (NCT06466889)
- Where
- Switzerland
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- University of Zurich
Allergic Diseases, Asthma
Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders
This study aims to build up a clinico-biological bank of samples from patients suspected of or suffering from allergic diseases (including asthma) or mast cell diseases in order to support future research in the field of allergic…
- Conditions
- Allergic Diseases, Asthma, Mast Cell Disorders
- Trial name
- BIRD-A (NCT06037967)
- Where
- France
- Volunteers
- 3,200 people
- Sponsor
- University Hospital, Toulouse
Clonal Mast Cell Disease, KIT D816V Mutation
Screening Study for KIT D816V Mutated Mast Cell Disease in Select Populations
This is a multicenter screening study to characterize the prevalence of the KIT D816V mutation in participants with suspected clonal mast cell disease.
- Conditions
- Clonal Mast Cell Disease, KIT D816V Mutation, Suspected KITD816V Mutated Clonal Mast Cell Disease
- Trial name
- POLARIS (NCT07143669)
- Testing
- Screening
- Where
- 26 sites in United States, Belgium
- Volunteers
- 750 people
- Sponsor
- Blueprint Medicines Corporation
Mastocytosis, Monoclonal
Study of Factors Regulating Mast Cell Proliferation
This study will examine growth factors that promote and inhibit mast cell proliferation resulting in mastocytosis, a disease of excessive mast cells in the body.
- Conditions
- Mastocytosis, Monoclonal, Bone Marrow, Tryptase
- Trial name
- NCT00044122
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
IBS (Irritable Bowel Syndrome)
Study Evaluating the Effect of UCB8600 on Mast Cell Activation in the Human Gut
Study evaluating the effect of UCB8600 on mast cell activation in the human gut: IBS is a disease characterized by abdominal pain and a change in stool.
- Trial name
- MASTGUT (NCT07655375)
- Testing
- Sample collection
- Where
- Belgium
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Guy Boeckxstaens