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Clinical trials for Mastocitosis

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    14 result(s) found for: Mastocitosis. Displaying page 1 of 1.
    EudraCT Number: 2010-019189-94 Sponsor Protocol Number: CLMAST01 Start Date*: 2010-07-22
    Sponsor Name:Dr. Luis Escribano
    Full Title: Tratamiento con inhibidores de tirosina quinasas en pacientes con variantes de mastocitosis sistémica de mal pronóstico: ensayo clínico para sujetos sin mutación D816V de KIT y búsqueda de inhibido...
    Medical condition: Mastocitosis sistémica
    Disease: Version SOC Term Classification Code Term Level
    11 10042949 Mastocitosis sistémica LLT
    11 10056453 Mastocitosis sistémica agresiva LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-006275-20 Sponsor Protocol Number: LP0074-33 Start Date*: 2012-08-20
    Sponsor Name:LEO Pharma A/S
    Full Title: A phase II exploratory study evaluating the efficacy of topical cromoglicate solution(20mg/ml) compared to topical solution vehicle in the treatment of mastocytosis
    Medical condition: mastocytosis
    Disease: Version SOC Term Classification Code Term Level
    15.0 10040785 - Skin and subcutaneous tissue disorders 10012812 Diffuse cutaneous mastocytosis PT
    15.0 10005329 - Blood and lymphatic system disorders 10056452 Indolent systemic mastocytosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-003268-25 Sponsor Protocol Number: RC31/19/0504 Start Date*: 2020-10-08
    Sponsor Name:CHU Toulouse
    Full Title: Hydroxychloroquine in isolated cutaneous mastocytosis patients or indolent systemic mastocytosis with associated skin involvement patients: proof of concept study
    Medical condition: mastocytosis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10042949 Systemic mastocytosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-006183-11 Sponsor Protocol Number: CA180-287 Start Date*: 2010-01-22
    Sponsor Name:UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II
    Full Title: Multicenter, Open-Label, Single Arm Phase II Clinical Trial of Dasatinib in the Treatment of Systemic Mastocytosis (SM)
    Medical condition: Systemic mastocytosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10042949 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-021001-21 Sponsor Protocol Number: SMART-2010-1 Start Date*: 2010-09-27
    Sponsor Name:Allergie-Centrum-Charité
    Full Title: An exploratory, randomised, double-blind, placebo controlled crossover study to assess the efficacy of 20 mg Rupatadine on the treatment of mastocytosis symptoms
    Medical condition: Mastocytosis is characterized by an excessive increase in the number of mast cells in different tissues. Symptoms result either from organ infiltration or frequently from the release of proinflamma...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10052577 Pure dermal mastocytosis LLT
    12.1 10056452 Indolent systemic mastocytosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-006704-10 Sponsor Protocol Number: MICUMA Start Date*: 2007-03-16
    Sponsor Name:JADO Technologies GmbH
    Full Title: Efficacy and Safety of Miltefosine in Cutaneous Mastocytosis
    Medical condition: chronic stable symptomatic maculopapulous cutaneous mastocytosis or systemic mastocytosis with involvement of the skin and with positive Darier´s sign
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012812 Diffuse cutaneous mastocytosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004113-85 Sponsor Protocol Number: PA101-SM-02 Start Date*: 2015-04-16
    Sponsor Name:Patara Pharma, LLC
    Full Title: Randomized, Double-blind, Placebo-controlled, Crossover Design, Efficacy and Safety Study with PA101 in Patients with Indolent Systemic Mastocytosis
    Medical condition: Indolent Systemic Mastocytosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10005329 - Blood and lymphatic system disorders 10042949 Systemic mastocytosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-001447-39 Sponsor Protocol Number: AB15003 Start Date*: 2019-10-21
    Sponsor Name:AB SCIENCE
    Full Title: A 24-week with possible extension, prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, phase III study to compare efficacy and safety ...
    Medical condition: Smouldering or Indolent Severe Systemic mastocytosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) DE (Ongoing) PL (Ongoing) RO (Ongoing) LT (Completed) NL (Temporarily Halted) IT (Restarted)
    Trial results: (No results available)
    EudraCT Number: 2008-000280-42 Sponsor Protocol Number: CPKC412D2201 Start Date*: 2008-08-07
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A single arm, Phase II, Open-label Study to determine the efficacy of 100 mg twice daily oral dosing of midostaurin administered to patients with Agressive Systemic Mastocytosis or Mast Cell Leukem...
    Medical condition: Agressive Systemic Mastocytosis (ASM) or Mast Cell Leukemia (MCL) +/- an Associated Hematological Clonal Non-Mast Cell Lineage Disease (AHNMD)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004851 10056453 Aggressive systemic mastocytosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) IT (Completed) DE (Completed) NO (Completed) AT (Completed) GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2022-001535-87 Sponsor Protocol Number: BLU-263-2101 Start Date*: 2023-02-03
    Sponsor Name:Blueprint Medicines Corporation
    Full Title: A Phase 1/2, open-label, 2-arm study evaluating BLU-263 as monotherapy and in combination with azacitidine, in patients with KIT altered hematologic malignancies
    Medical condition: Advanced Systemic Mastocytosis (AdvSM)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10042949 Systemic mastocytosis PT
    26.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10056453 Aggressive systemic mastocytosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-000588-99 Sponsor Protocol Number: BLU-285-2203 Start Date*: 2019-03-15
    Sponsor Name:Blueprint Medicines Corporation
    Full Title: A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indole...
    Medical condition: Indolent Systemic Mastocytosis (ISM)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10042949 Systemic mastocytosis PT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10056452 Indolent systemic mastocytosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Ongoing) DE (Ongoing) ES (Ongoing) NL (Ongoing) DK (Ongoing) IT (Ongoing) SE (Ongoing) FR (Ongoing) NO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-001010-10 Sponsor Protocol Number: CGT9486-20-201 Start Date*: 2021-12-09
    Sponsor Name:Cogent Biosciences, Inc.
    Full Title: A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis
    Medical condition: Advanced Systemic Mastocytosis (AdvSM)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10056453 Aggressive systemic mastocytosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) NO (Ongoing) IT (Ongoing) AT (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-004836-13 Sponsor Protocol Number: BLU-285-2202 Start Date*: 2018-12-29
    Sponsor Name:Blueprint Medicines Corporation
    Full Title: An Open-label, Single Arm, Phase 2 Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients with Advanced Systemic Ma...
    Medical condition: Advanced Systemic Mastocytosis (AdvSM)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10056453 Aggressive systemic mastocytosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) GB (GB - no longer in EU/EEA) DE (Ongoing) ES (Ongoing) PL (Completed) AT (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-000972-25 Sponsor Protocol Number: AB06006 Start Date*: 2013-06-06
    Sponsor Name:AB SCIENCE
    Full Title: A 24-week with possible extension, prospective, multicentre, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, Phase III study to compare efficacy and safety ...
    Medical condition: Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis with handicaps
    Disease: Version SOC Term Classification Code Term Level
    9.1 10026891 Mastocytosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) CZ (Completed) SK (Completed) LV (Completed) AT (Completed) DE (Prohibited by CA) GB (Completed) IT (Completed) BG (Completed) HU (Completed) GR (Completed) ES (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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