Clinical trials: Mastocytosis, Systemic
High-risk Myelodysplastic Syndromes, Acute Myelogenous Leukemia
GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies
This is a multi-center Phase I/II clinical trial of GTB-3550 (CD16/IL-15/CD33) tri-specific killer cell engager (TriKE®) for the treatment of CD33-expressing high risk myelodysplastic syndromes, refractory/relapsed acute myeloid…
- Conditions
- High-risk Myelodysplastic Syndromes, Acute Myelogenous Leukemia, Systemic Mastocytosis, Mast Cell Leukemia
- Trial name
- NCT03214666
- Testing
- GTB-3550 TriKE® Phase I, GTB-3550 TriKE® Phase II
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- GT Biopharma, 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
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 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
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
Advanced Systemic Mastocytosis
Study of Elenestinib (BLU-263) in Advanced Systemic Mastocytosis (AdvSM) and and Other KIT Altered Hematologic Malignancies
The goal of this clinical trial is to evaluate elenestinib (BLU-263) in participants with Advanced Systemic Mastocytosis (AdvSM), SM with an associated hematologic neoplasm (SM-AHN), and other hematologic malignancies.
- Trial name
- AZURE (NCT05609942)
- Testing
- BLU-263, Azacitidine
- Where
- 11 sites in United States, Belgium and 5 more
- Volunteers
- 9 people
- Sponsor
- Blueprint Medicines Corporation
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.
Aggressive Systemic Mastocytosis, Systemic Mastocytosis-associated Hematologic Non-mast Cell Disease
(EXPLORER) Study of BLU-285 in Patients With Advanced Systemic Mastocytosis (AdvSM) and Relapsed or Refractory Myeloid Malignancies
This is a Phase 1, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of avapritinib (also known as BLU-285), administered…
- Conditions
- Aggressive Systemic Mastocytosis, Systemic Mastocytosis-associated Hematologic Non-mast Cell Disease, Mast Cell Leukemia, Relapsed or Refractory Myeloid Malignancies
- Trial name
- NCT02561988
- Testing
- Avapritinib
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 86 people
- Sponsor
- Blueprint Medicines Corporation