Phase 2 Leukaemia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Main Study

• People who have been diagnosed with advanced mastocytosis — specifically Aggressive Systemic Mastocytosis (ASM), Systemic Mastocytosis with an Associated Blood Cancer (SM-AHN), or Mast Cell Leukemia (MCL), as confirmed by the trial's Eligibility Committee
• People whose disease can be measured using specific standard criteria set for mastocytosis (a small group whose disease cannot be measured this way may also be included)
• People with a general health/activity score between 0 and 3 on a standard medical scale (confirm with trial site)
• People whose recent blood and chemistry test results fall within acceptable ranges set by the trial

Substudy – Rollover Group (for people already receiving the study drug, bezuclastinib)

• People whose associated blood cancer has progressed and now needs immediate treatment while they are already receiving bezuclastinib
• People who have shown a clinical benefit from bezuclastinib treatment
• People whose recent blood and chemistry test results fall within acceptable ranges set by the trial

Substudy – High-Risk Group

• People who are currently receiving, or have been identified as needing, treatment directed at their associated blood cancer
• People diagnosed with SM-AHN alongside one of these specific blood conditions: high- or very high-risk myelodysplastic syndrome (MDS), accelerated-phase myeloproliferative neoplasm (MPN), MDS with too many abnormal cells in the bone marrow or blood, or a condition called CMML-2
• People whose recent blood and chemistry test results fall within acceptable ranges set by the trial

Who may not be able to join:

Main Study

• People who still have side effects from a previous mastocytosis treatment that have not reduced to a mild level (Grade 1 or lower)
• People whose associated blood cancer needs immediate treatment right away
• People with a serious heart condition
• People who test positive for a specific genetic change called FIP1L1-PDGFRA fusion (people with high eosinophil counts and no detectable KIT D816V mutation must have this genetic test result available before joining)
• People who are HIV positive, or who test positive for Hepatitis B or Hepatitis C
• People who have had a significant bleeding event in the 30 days before starting the study drug, or who need ongoing blood-thinning medication during the study
• People who have been diagnosed with or treated for another cancer (other than the mastocytosis being studied) within the past 3 years
• People who have received certain cell-reducing treatments or experimental drugs too recently before the screening bone marrow test (specific waiting periods apply depending on the type of treatment — confirm with trial site)
• People who have received blood cell growth factor support within 14 days before starting the study drug
• People who have taken certain medications that strongly affect how the body processes drugs (strong CYP3A4 inhibitors or inducers) within 14 days, or within 5 half-lives of that drug, whichever is longer, before starting the study drug
• People who need to take high-dose steroid medication

Substudy – Rollover Group

• People who did not tolerate bezuclastinib well enough in previous treatment

Substudy – High-Risk Group

• People with a type of blood cancer linked to the Philadelphia chromosome
• People diagnosed with acute myeloid leukemia (AML)
• People considered suitable for a stem cell transplant from a donor
• People who have a medical reason they cannot take the other medications used alongside the study drug
• People who have previously been treated with an experimental therapy for advanced mastocytosis
• People who previously received cell-reducing therapy but had to stop because of serious side effects from that treatment
• People who have received certain cell-reducing treatments or experimental drugs too recently before the screening bone marrow test (specific waiting periods apply depending on the type of treatment — confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.