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:

• People who are reasonably active and able to care for themselves, with a daily functioning score rated at 0, 1, or 2 on a standard oncology scale (called ECOG performance status)
• People whose cancer has been tested by a local lab and found to have a specific gene mutation called IDH1-R132 (certain other related mutations may also be considered after discussion with the lead doctor)
• People with a blood cancer called AML (acute myeloid leukemia) who have either never received treatment before, or whose cancer has come back or stopped responding to treatment, and who are considered suitable for intensive chemotherapy; people with high-risk MDS or MPN (other blood or bone marrow conditions rated as high-risk by standard scoring systems) may also be considered after discussion with the lead doctor
• People whose liver is working well enough, based on blood test results within acceptable ranges
• People whose kidneys are working well enough, based on a standard calculation of kidney filtering ability
• People who are willing and able to give their informed consent to participate
• People whose last cancer treatment was given at least 7 days before starting the trial (unless their disease is growing very rapidly)
• Male participants who agree to use protected sex and avoid sperm donation from the first dose of study medication until 90 days after the last dose

Who may not be able to join:

• People who have previously received a chemotherapy drug called CPX-351
• People who have another serious, uncontrolled medical condition, infection, significant abnormal lab results, or mental health condition that could put them at unacceptable risk
• People who are receiving other chemotherapy or anti-leukemia treatments at the same time (with limited exceptions: chemotherapy given directly into the spinal fluid for prevention or controlled disease in the brain or spine is allowed; a short course of hydroxyurea and/or low-dose cytarabine may be allowed before starting the trial for people with rapidly growing disease)
• People who have active graft-versus-host disease (a complication that can occur after a stem cell transplant) — though people with stable, chronic, well-managed graft-versus-host disease may be considered after discussion with the lead doctor
• People with serious digestive or metabolic problems that could prevent the body from properly absorbing the oral study medications
• People with significant heart problems, including severe heart failure (rated Class III or IV on a standard scale), unstable chest pain, or a heart pumping function below 45%
• People who have previously received high doses of a type of chemotherapy called anthracyclines, above specified limits (or lower limits if they have also had radiation to the chest area)
• People with an abnormally long heart electrical interval (called QTcF greater than 470 milliseconds) on a heart tracing test — a specific exception may be discussed with the lead doctor for certain heart rhythm variations
• Women who are breastfeeding, women who could become pregnant and have a positive pregnancy test, or women who could become pregnant and are not willing to use highly effective contraception (such as hormonal birth control, an IUD, or a condom used together with a spermicide)
• People with a known history of a serious brain condition called progressive multifocal leukoencephalopathy (PML)
• People taking certain strong medications that affect how the body breaks down drugs (called strong CYP3A4 inducers), unless those medications can be switched to alternatives at least 5 half-lives before starting the trial
• People diagnosed with a specific type of blood cancer called acute promyelocytic leukemia (APL)
• People who still have side effects from a previous treatment (rated above grade 1 in severity) that have not yet resolved

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