RecruitingPhase II🇵🇱 PolandEN originalLeukemiaOther cancers

(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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 (SM-AHN), and Mast Cell Leukemia (MCL).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Diagnoza jednej z zaawansowanych postaci mastocytozy układowej: ostra, z towarzyszącymi nowotworami krwi lub białaczka z komórek tucznych.
  • Choroba dająca się zmierzyć.
  • Stan ogólny pozwalający na udział w badaniu (skala ECOG od 0 do 3).
  • Wyniki podstawowych badań krwi i moczu w normie lub w akceptowalnych granicach.

✗ Disqualifies

  • Uporczywe skutki uboczne po poprzednim leczeniu, które nie ustąpiły do łagodnego stopnia.
  • Potrzeba natychmiastowego leczenia z powodu towarzyszącego nowotworu krwi.
  • Znaczne problemy z sercem.
  • Potwierdzona mutacja FIP1L1 PDGFRA. Osoby z podwyższoną liczbą eozynofili, bez mutacji KIT D816V, muszą mieć wykluczoną mutację PDGFRA przed rozpoczęciem badania.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 31, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (42)

University of Alabama at Birmingham (UAB) Hospital

Birmingham, United States

Mayo Clinic Arizona

Phoenix, United States

City of Hope Comprehensive Cancer Center

Duarte, United States

UCLA Medical Center

Los Angeles, United States

Stanford Cancer Institute

Stanford, United States

Galiz Research

Hialeah, United States

Winship Cancer Institute - Emory University

Atlanta, United States

Rush University Medical Center

Chicago, United States

Dana-Farber Cancer Institute

Boston, United States

Columbia University Irving Medical Center

New York, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, United States

MUSC Health University Medical Center

Charleston, United States

The University of Texas MD Anderson Cancer Center

Houston, United States

Huntsman Cancer Institute - University of Utah Health

Salt Lake City, United States

Nepean Hospital

Kingswood, Australia

Gold Coast University Hospital

Southport, Australia

Peter MacCallum Cancer Centre

Melbourne N., Australia

AKH Wien, Universitatsklinikum

Vienna, Austria

CHU de Liege

Liège, Belgium

University of Alberta Hospital

Edmonton, Canada

St. Michael's Hospital - Unity Health Toronto

Toronto, Canada

Necker-Enfants Malades Hospital

Paris, France

Centre Hospitalier Universitaire (CHU) de Poitiers

Poitiers, France

Centre Hospitalier Universitaire (CHU) de Toulouse

Toulouse, France

University Hospital Aachen

Aachen, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

UKSH Campus Lubeck

Lübeck, Germany

Universitätsklinikum Mannheim

Mannheim, Germany

IRCCS Azienda Ospedaliero Universitaria di Bologna

Bologna, Italy

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

AOU San Giovanni di Dio e Ruggi dAragonia

Salerno, Italy

Azienda Ospidaleira Universitaria Integrata Verona

Verona, Italy

University Medical Center Groningen

Groningen, Netherlands

Oslo University Hospital

Oslo, Norway

Public University Hospital No. 1 in Lublin

Lublin, Poland

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Institut Català d'Oncologia - Hospital Duran i Reynals

Barcelona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Universitätsspital Basel

Basel, Switzerland

Guy's Hospital - NHS Foundation Trust

London, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

University College London Hospital - NHS Foundation Trust

London, United Kingdom

Trial contact

Cogent Biosciences, Inc.

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/1/2026.

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