This study is not accepting new patients

Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis

a study on Systemic Mastocytoses, Indolent Systemic Mastocytoses, Aggressive Advanced Systemic Mastocytosis Leukemia

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started

Description

Summary

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 have received and failed or been intolerant to at least one standard approved therapy and/or have no comparable or satisfactory alternative therapy options.

Official Title

Intermediate-Size Patient Population Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis

Keywords

Systemic Mastocytoses, Indolent, Systemic Mastocytoses, Aggressive, Systemic Mastocytosis, NonAdvanced Systemic Mastocytosis, Advanced Systemic Mastocytosis, Systemic Mastocytosis with an associated hematologic neoplasm (SM-AHN), Aggressive Systemic Mastocytosis (ASM), Mast Cell Leukemia (MCL), Bone Marrow Mastocytosis (BMM), Mast-Cell Leukemia, Bezuclastinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • Able to provide written informed consent and commit to EAP assessments.
  • ≥18 years of age.
  • Able to swallow tablets.
  • Diagnosed with ASM, SM-AHN, MCL, BMM, ISM, or SSM according to the 2022 WHO Classification for SM
  • Not receiving adequate disease control on current therapy(ies).
  • Have clinically acceptable laboratory screening results.

You CAN'T join if...

  • Patients who are eligible for and/or enrolled in an on-going bezuclastinib clinical trial.
  • Patients who discontinued investigational use of bezuclastinib in previous clinical trials due to toxicity or withdrawal of consent.
  • Pregnant or currently breastfeeding.
  • Prior or ongoing clinically significant illness or medical or physical condition

Other protocol-defined criteria apply.

Locations

  • UCLA Ronald Reagan Medical Center not accepting new patients
    Los Angeles California 90095 United States
  • Orso Health/Modena Asthma Allergy not accepting new patients
    La Jolla California 92037 United States
  • Scripps Green Hospital not accepting new patients
    La Jolla California 92037 United States

Details

Status
not accepting new patients
Start Date
Sponsor
Cogent Biosciences, Inc.
ID
NCT06915766
Study Type
Expanded Access
Last Updated
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