Phase 1 Leukaemia Trial, Recruiting

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

Who might be able to join this trial:

• People aged 18 or older who have been diagnosed with CML in accelerated phase, CML in blast phase, or Philadelphia chromosome-positive acute myeloid leukaemia (a specific type of blood cancer), according to standard 2016 diagnostic criteria
• People whose disease did not respond well to, or who could not tolerate, at least one prior targeted therapy (called a BCR::ABL1 TKI) for their condition
• People with a general health/functioning level rated at 3 or below on the ECOG scale (confirm with trial site for exact details)
• People whose liver, heart, kidneys, and pancreas are functioning well enough to meet specific blood test and measurement thresholds set by the trial (confirm with trial site for exact values)
• People who are able to understand the trial and are willing to sign a written consent form
• People who are willing to use effective contraception during the trial and for 6 months after it ends (several approved methods are listed, including hormonal contraception, IUDs, abstinence, and others)

Who may not be able to join:

• People who have previously been treated with lisaftoclax or olverembatinib (the study drugs)
• People who have had acute pancreatitis within the past year, or who have a history of chronic pancreatitis
• People with severe heart failure (Grade III–V as classified by a standard medical scale)
• People with significant uncontrolled heart or blood vessel problems, including: a heart attack, stroke, unstable chest pain, or mini-stroke within the past 6 months; reduced heart pumping function below normal range; a known or suspected heart rhythm condition called long QT syndrome; certain serious uncontrolled heart rhythm problems; an abnormally prolonged heart electrical reading (QTc above 480 milliseconds) that does not correct after treatment; a blood clot in a vein or lung within the past 3 months (with some exceptions); or severely uncontrolled high blood pressure
• People with a serious active infection that is not being controlled by antibiotics
• People with leukaemia that has spread to the brain or spinal fluid
• People who are HIV-positive, unless their HIV is well-controlled on a stable treatment regimen
• People who test positive for active hepatitis B surface antigen, or who have a detectable hepatitis B viral load; or people with suspected active hepatitis C infection with a detectable viral load
• People with another current or past cancer, unless the treating team and trial lead agree it will not interfere with the trial (decided case by case)
• People who have taken certain strong medications (called CYP3A or p-glycoprotein inducers, such as carbamazepine, phenytoin, rifampin, or St. John's Wort) within 14 days before starting the trial, or within 5 half-lives of that medication — whichever period is longer
• People who have received other experimental anti-leukaemia treatments or chemotherapy in the 7 days before starting the trial, unless they have fully recovered from side effects or have rapidly worsening, life-threatening disease (some exceptions apply — confirm with trial site)
• People who are unable to swallow tablets or capsules
• People who are pregnant or breastfeeding
• People who have had a serious allergic reaction to drugs with a similar chemical makeup to the study medications (decitabine, lisaftoclax, or olverembatinib)
• People with psychiatric illness or personal circumstances that would make it difficult to follow the trial's requirements

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