Clinical trials: Indolent Systemic Mastocytosis
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
Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis
The objective of this study is to compare the safety and efficacy of masitinib (AB1010) to placebo in patients with mastocytosis with handicap.
- Trial name
- AB06006 (NCT00814073)
- Testing
- Masitinib, Best Supportive Care
- Where
- 24 sites in United States, France
- Volunteers
- 135 people
- Sponsor
- AB Science
Systemic Mastocytoses, Indolent, Systemic Mastocytoses, Aggressive
Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
The purpose of this expanded access program (EAP) protocol is to provide investigational bezuclastinib to patients with a diagnosis of nonadvanced systemic mastocytosis (NonAdvSM) or advanced systemic mastocytosis (AdvSM) who…
- Trial name
- NCT06915766
- Testing
- Bezuclastinib
- Where
- 23 sites in United States
- Sponsor
- Cogent Biosciences, Inc.
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
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
Indolent Systemic Mastocytosis
Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis Unresponsive to Optimal Symptomatic Treatment
The purpose of this study is to evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients suffering from smouldering or indolent systemic mastocytosis with severe symptoms of mast cell…
- Trial name
- NCT04333108
- Testing
- Masitinib, Best Supportive Care
- Where
- 17 sites in France, Germany and 6 more
- Volunteers
- 140 people
- Sponsor
- AB Science
SSM, Mastocytosis, Indolent
(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis
This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study comparing the safety and efficacy of bezuclastinib (CGT9486) plus best supportive care (BSC) with placebo plus BSC in patients with…
- Conditions
- SSM, Mastocytosis, Indolent, Mastocytosis, Systemic, Mastocytosis
- Trial name
- NCT05186753
- Testing
- Bezuclastinib Tablets (Formulation A), Bezuclastinib Tablets (Formulation B)
- Where
- 57 sites in United States, Australia and 13 more
- Volunteers
- 237 people
- Sponsor
- Cogent Biosciences, Inc.
Indolent Systemic Mastocytosis
(PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo in Patients With Indolent Systemic Mastocytosis
This is a Phase 2, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of avapritinib + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose…
- Trial name
- NCT03731260
- Testing
- Avapritinib
- Where
- 49 sites in United States, Belgium and 11 more
- Volunteers
- 251 people
- Sponsor
- Blueprint Medicines Corporation
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
Indolent Systemic Mastocytosis
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK002
This is a Phase 1 study to investigate the safety and tolerability of AK002 in patients with indolent systemic mastocytosis (ISM).
- Trial name
- NCT02808793
- Testing
- AK002
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Allakos Inc.
Mastocytosis
Mast Cell Connect: A Registry for Patients With Mastocytosis
The Mast Cell Connect Registry is a voluntary, observational database that will capture demographic, socioeconomic, and disease information directly from patients with mastocytosis via a secure web-based tool.
- Trial name
- NCT02620254
- Where
- United States
- Volunteers
- 743 people
- Sponsor
- Blueprint Medicines Corporation
Aggressive Systemic Mastocytosis (ASM), SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD)
Patient-Reported Outcome Questionnaire for Systemic Mastocytosis
The purpose of this study is to explore the key symptoms of individuals with systemic mastocytosis. Interviews of enrolled individuals will be conducted to learn about the disease symptoms and condition.
- Conditions
- Aggressive Systemic Mastocytosis (ASM), SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD), Mast Cell Leukemia (MCL), Smoldering Systemic Mastocytosis (SSM)
- Trial name
- NCT02380222
- Testing
- Interview
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Adelphi Values LLC
Mastocytosis, Systemic Mastocytosis
Treatment of Indolent Systemic Mastocytosis With PA101
This is a randomized, placebo- and active-controlled, 2-period crossover, 2 cohort study in adult patients with indolent systemic mastocytosis (ISM).
- Conditions
- Mastocytosis, Systemic Mastocytosis, Indolent Systemic Mastocytosis
- Trial name
- NCT02478957
- Testing
- PA101
- Where
- 8 sites in France, Germany and 3 more
- Volunteers
- 41 people
- Sponsor
- Patara Pharma
Mastocytosis
Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis
This is a 12 weeks study aimed at assessing the safety and efficacy of 2 doses of AB1010 in patients suffering from indolent systemic mastocytosis with handicap.
- Trial name
- NCT00831974
- Testing
- masitinib (AB1010)
- Volunteers
- 23 people
- Sponsor
- AB Science
Myelofibrosis, Indolent Systemic Mastocytosis
Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5).
- Trial name
- NCT04655118
- Testing
- TL-895
- Where
- 52 sites in United States, Australia and 11 more
- Volunteers
- 121 people
- Sponsor
- Telios Pharma, Inc.