Phase 2 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 are 12 years of age or older at the time of signing the consent form.
• People who weigh at least 40 kg (approximately 88 pounds).
• People who are willing and able to attend scheduled study visits and follow the study requirements.
• People who have been diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or mixed phenotype acute leukemia that has come back or stopped responding to treatment, and who have already tried at least one prior treatment.
• People whose leukemia has tested positive for a specific genetic marker — either a change in the NPM1 gene, or a rearrangement involving the KMT2A or NUP98 genes — confirmed through an approved laboratory test.
• People whose prior menin inhibitor treatment history matches the requirements of the specific part of the trial they would be enrolling in: Phase 1 has no requirement; Phase 2 Cohort 1 requires no prior menin inhibitor treatment; Phase 2 Cohort 2 requires prior menin inhibitor treatment (confirm with trial site).
• People who have had a stem cell transplant from a donor, provided at least 60 days have passed since the transplant and at least 4 weeks have passed since any donor lymphocyte infusion.
• People whose general physical functioning meets the age-appropriate performance scale used in the trial (scored as reasonably functional — confirm details with trial site).
• People whose white blood cell count is below 25,000/μL at the time of starting the study drug (certain treatments to lower this count beforehand may be allowed).
• People whose liver, kidney, and heart function meet the minimum levels required by the trial, as measured by standard blood and imaging tests.

Who may not be able to join:

• People diagnosed with a specific subtype of leukemia called acute promyelocytic leukemia.
• People whose only site of disease is an isolated myeloid sarcoma (a tumour outside the bone marrow).
• People who have previously received the drug mezigdomide.
• People experiencing severe, immediately life-threatening complications of leukemia, such as uncontrolled bleeding, pneumonia with low oxygen levels or shock, a serious blood-clotting disorder, or uncontrolled tumour lysis syndrome.
• People who have another condition that the treating doctor believes would make participation unsafe or inappropriate.
• People who have another active cancer that could interfere with the trial's results.
• People who have received other anti-leukemia treatments too recently before the study drug starts, unless the treatment falls into a permitted category (such as hydroxyurea, corticosteroids, certain forms of chemotherapy, or spinal chemotherapy — confirm with trial site).
• People with moderate to severe graft-versus-host disease (a complication after donor stem cell transplants) that requires systemic treatment; skin-only graft-versus-host disease managed with topical creams alone would not prevent participation.
• People who have had a significant heart condition — such as severe heart failure, a heart attack, or a stroke — within the 6 months before starting the study drug.
• People with a heart electrical measurement called QTcF of 450 ms or more on an ECG, or other factors that raise the risk of dangerous heart rhythm problems (exceptions may be considered for certain heart conditions with the lead investigator's approval — confirm with trial site).
• People with an active HIV infection, or an active hepatitis B or hepatitis C infection.
• People who have difficulty swallowing, or a condition that affects the body's ability to absorb medication taken by mouth.
• People with an active infection (fungal, bacterial, or viral) that is not under control despite appropriate treatment.
• People currently taking certain medications known as strong or moderate CYP3A4 inhibitors, or strong CYP3A4 inducers (confirm which medications apply with the trial site).
• People who have used proton pump inhibitors (a type of medication for stomach acid) within 2 weeks before starting treatment.
• People who are pregnant or breastfeeding; also, people who are not willing to use contraception for the required period after the last dose of the study drug (4 months for males, 6 months for females — confirm full requirements with trial site).

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