Phase 2 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 60 years or older who have been newly diagnosed with acute myeloid leukemia (AML), including AML that developed from a previous blood condition or as a result of past cancer treatment.
• People whose doctor considers them well enough to receive intensive chemotherapy.
• People whose leukemia cells have certain detectable features that allow a specific type of disease monitoring (required for Phase II of the trial only — confirm with trial site).
• People with a general health performance score of 2 or less on a standard medical scale (meaning they are able to care for themselves and are up and about more than half of waking hours — confirm with trial site).
• People whose liver function blood test results are within an acceptable range, as set out in the trial criteria (confirm with trial site).
• People whose kidneys are filtering at an acceptable level, based on a standard calculation (confirm with trial site).
• People who have given written consent before any trial screening procedures take place.
• People who are covered by the French National Health Insurance system.

Who may not be able to join:

• People whose leukemia is found mostly outside the bone marrow (a form called myeloid sarcoma) with fewer than 20% leukemia cells in the bone marrow.
• People who have received a live-attenuated (live virus) vaccine within the three weeks before joining the trial.
• People whose leukemia has spread to the central nervous system (brain and spinal cord).
• People whose leukemia falls into a "favourable risk" category based on specific genetic features (confirm with trial site for details).
• People whose leukemia has a specific genetic change (FLT3-ITD or TKD mutation) that requires treatment with a drug called midostaurin.
• People who have received any cancer-killing treatment within three weeks before the first study dose, except for a drug called hydroxyurea used to manage blood cell counts.
• People who are planned to receive a specific treatment called CPX-351 for their type of AML.
• People who have been treated with sulfasalazine in the last five years, or who are currently being treated with sulfasalazine or a related drug called 5-aminosalicylic acid (5-ASA) for ulcerative colitis or inflammatory joint conditions.
• People with a known allergy to sulfasalazine or any of its components, related drugs, or to the chemotherapy drugs idarubicin or cytarabine, or any of their ingredients.
• People with a genetic condition called glucose-6-phosphate dehydrogenase deficiency.
• People with a condition called acute intermittent porphyria or porphyria variegata (rare disorders affecting how the body processes certain substances).
• People with an active, uncontrolled infection (fungal, bacterial, or viral) that is not improving with appropriate treatment.
• People who have had another active cancer in the past 12 months, with some exceptions such as certain skin cancers, early-stage cervical or breast carcinoma, or other locally treated cancers (confirm with trial site).
• People known to have HIV or an HIV-related cancer.
• People with a currently active hepatitis B or hepatitis C infection.
• People who are unable to swallow, or who have a condition that significantly affects how the body absorbs oral medications.
• People who are currently taking part in another interventional clinical trial, or who have done so within 30 days of enrolling.
• People who have received an experimental (investigational) therapy within a specified period before the first dose of the study drug (confirm with trial site for exact timing).
• People who have previously been treated with a class of drugs called anthracyclines (a type of chemotherapy).
• People who have a heart-related condition or other medical reason that would prevent them from safely receiving anthracycline chemotherapy, including certain heart conditions, severe kidney or liver failure, or a reduced heart pumping function below a specified level (confirm with trial site).
• People who have a condition that would prevent them from safely receiving cytarabine chemotherapy, including certain brain conditions (confirm with trial site).
• People who require ongoing treatment with a heart medication called digoxin.
• People with any other serious, uncontrolled medical condition that could affect their safe participation in the trial.
• People who are pregnant or breastfeeding.
• Men whose sexual partner could become pregnant, if they or their partner are unwilling or unable to use a highly effective form of contraception throughout the treatment period and for at least six months after treatment ends. Male participants must also not donate or freeze sperm from the start of screening until three months after the final dose.
• Women who could become pregnant and are unwilling or unable to use a highly effective form of contraception throughout the treatment period and for at least six months after the final dose. Women who have not had a period for at least two years, or who have had a surgical procedure to prevent pregnancy, may not be considered of childbearing potential (confirm with trial site). Female participants must also not donate eggs from screening until 12 weeks after the final dose, and must agree not to breastfeed during the trial period and for a specified time after the final dose.
• People who are under a legal protection order or who are unable to give their own informed consent.
• People who are deprived of their freedom by a court or administrative decision, or who are hospitalised without their consent under specific French public health laws, unless a specific exemption applies (confirm with trial site).

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