Phase 1 Lymphoma 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:

• People who have been diagnosed with a specific type of blood cancer — CD19-positive, BCR-ABL1-positive acute leukemia (including B-cell ALL, mixed phenotype acute leukemia, or CML in lymphoid blast crisis with a certain level of abnormal cells) — confirmed through laboratory testing.
• People whose leukemia has spread to the central nervous system (brain/spinal fluid) but is not causing symptoms may still be considered eligible, and may receive spinal chemotherapy at the same time.
• During the dose escalation phase: people who are not suitable for, or do not wish to receive, standard intensive chemotherapy.
• During the dose expansion phase: people aged 18 and older, regardless of whether standard intensive chemotherapy is an option.
• People aged 50 and over who have not yet received standard intensive induction chemotherapy.
• People aged 18 to 49 who have not yet received standard intensive induction chemotherapy and have health conditions that make intensive chemotherapy too risky — such as serious heart problems, serious lung problems, or other significant health conditions judged by a doctor to be incompatible with intensive chemotherapy.
• People aged 18 and over whose leukemia has come back or has not responded to one or more cycles of standard intensive chemotherapy.
• People with a general health/activity level that falls within an acceptable range on a standard medical scale (ECOG performance status 0–3), noting that a score of 3 may require additional discussion with the lead investigator and must be due to the disease itself rather than other causes.
• People whose kidneys, pancreas, and liver are functioning within acceptable ranges based on blood test results.
• People who are willing and able to use effective contraception throughout the study and for 30 days after treatment ends (for women of childbearing potential and sexually active men).
• People who are able to understand the study and are willing to sign a consent form and follow all study procedures.

Who may not be able to join:

• During the dose escalation phase only: people who are suitable for and willing to receive standard intensive induction chemotherapy.
• People who have a specific genetic mutation called ABL T315I (this is only routinely tested in people with relapsed disease or CML that has progressed on prior treatment).
• People who have previously been treated for ALL or CML with dasatinib or the study drug asciminib (prior use of other similar targeted therapies or chemotherapy is generally permitted).
• People who have received other chemotherapy or antibody-based treatments within 2 weeks before starting the study (with some exceptions such as steroids, hydroxyurea, ATRA, or spinal chemotherapy).
• People currently taking other experimental treatments for conditions other than ALL who have not stopped those treatments at least 2 weeks before starting the study.
• People with serious stomach or bowel problems that could significantly affect how the study drug is absorbed — such as active ulcers, uncontrolled nausea, vomiting, diarrhoea, or malabsorption conditions.
• People with another cancer that currently requires treatment or is likely to affect the safety or results of the study (some low-risk or early-stage cancers may be considered after discussion with the lead investigator).
• People with active or chronic liver disease, including active hepatitis B or C infections (people with a known past exposure to viral hepatitis may be considered if there is confirmed evidence of no active infection).
• People with a history of pulmonary arterial hypertension (high blood pressure in the lung arteries).
• People with large pleural effusions (fluid around the lungs) that are causing breathing difficulties and require drainage procedures.
• People with alcohol dependency requiring medical treatment.
• People with a current or past history of acute pancreatitis, chronic pancreatitis, or any ongoing pancreatic disease.
• People known to be HIV-positive.
• People with a history of a serious bleeding disorder unrelated to their leukemia.
• People taking certain medications that may interact with the study drug — including strong or moderate inhibitors or inducers of specific liver enzymes, or certain other drugs with a narrow range of safe dosing — may need to stop those medications before joining (confirm with trial site if this applies).
• People who consume grapefruit or grapefruit products, as these are not permitted during the study.
• People with a prolonged heart rhythm measurement (QTc greater than 480 milliseconds) on a heart tracing (ECG) taken before the study.
• People who have had major surgery within 2 weeks before the first dose of the study drug.
• People with uncontrolled ongoing illness, including uncontrolled infection, unstable heart conditions (such as severe heart failure, unstable chest pain, uncontrolled irregular heartbeat, or a heart attack or stroke within the past 3 months), or psychiatric or social circumstances that would make it difficult to follow the study requirements.
• People who currently require supplemental oxygen, mechanical breathing support, medications to support blood pressure, or dialysis.
• People who are unable to take medication by mouth.
• People who are pregnant or breastfeeding at the time of screening, as the study drug may be harmful to an unborn baby or infant.

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