Phase 3 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:

At the start of the trial (diagnosis stage):

• Adults aged 18 to 60 years old
• People who have been newly diagnosed with acute myeloid leukaemia (AML), whether it developed on its own or arose from a prior blood condition or previous cancer treatment
• People who have not yet received treatment for AML (a medication called hydroxyurea is the only exception) or for a prior blood condition called MDS (a medication called EPO is the only exception)
• People whose general health and ability to perform daily activities meets a certain minimum level, as measured by a standard medical scale (ECOG score of 3 or below)
• People who do not have a severe, uncontrolled infection at the time of joining
• People whose heart is functioning well enough — with no uncontrolled heart failure, no recent heart attack, no significant heart rhythm problems, and a heart pumping function (LVEF) of at least 50%
• People whose liver and kidney blood test results are within acceptable ranges (unless any abnormal results are caused by the AML itself)
• People who have had genetic testing done on their AML cells to check for a specific gene change called FLT3 (this can be done at a local or central laboratory)
• People who are willing and able to use reliable contraception during and after treatment (women of childbearing potential must use contraception throughout treatment and for 5 months after stopping; men must use condoms during treatment and for 5 months after stopping, if receiving a medication called Midostaurin)
• People who are enrolled in a social security or universal health coverage scheme
• People who have read, understood, and signed the informed consent form for the trial

Who may not be able to join (at the start of the trial):

• People diagnosed with a specific subtype of AML called acute promyelocytic leukaemia (APL), identified by certain genetic markers
• People whose AML is a specific subtype called core binding factor (CBF) AML, identified by certain chromosomal changes
• People whose AML developed from a prior condition called a myeloproliferative disorder (as classified under the 2008 WHO system)
• People whose AML is linked to a specific chromosomal abnormality called Philadelphia chromosome positive (Ph1+), or who previously had a related condition called chronic myelogenous leukaemia
• People with a serious psychiatric or physical condition unrelated to AML that would make the planned treatment, including a stem cell transplant, unsafe
• People who, for personal, social, or geographic reasons, would not be able to attend regular medical follow-up appointments
• People who have had another cancer that was not under control within the last 2 years (certain skin cancers and early-stage cervical changes are exceptions)
• People with a severe, uncontrolled infection
• People who test positive for HIV-1, HIV-2, HTLV-1, HTLV-2, or who have an active hepatitis B or C infection
• Women who are pregnant or breastfeeding
• People who are legally unable to give their own consent (for example, those under legal guardianship or court protection)

Who might be able to join — later stage (R4-VOS randomisation, after induction or salvage treatment):

• People already enrolled in this trial at diagnosis
• People whose AML has gone into first remission (the leukaemia is no longer detectable) after initial treatment or one round of salvage treatment, confirmed within the 15 days before this stage
• People whose AML is classified as favourable or intermediate risk according to the trial's own risk system
• People who were assigned to a specific treatment group in an earlier part of the trial (the intermediate-dose cytarabine arm)
• People whose general health meets a certain minimum level (ECOG score of 2 or below)
• People whose heart pumping function (LVEF) is at least 40%, measured by a specific heart scan
• People whose kidney and liver blood test results are within acceptable ranges for this stage
• People who have signed the informed consent form specifically for this part of the trial
• Women of childbearing potential who have had a negative pregnancy test within 8 days before this stage and who agree to use effective contraception during treatment and for 36 days after stopping; men must use effective contraception during treatment and for 96 days after stopping

Who may not be able to join — R4-VOS stage:

• People classified as unfavourable risk under the trial's risk system
• People whose AML has not gone into remission after initial and/or salvage treatment
• Women with a positive pregnancy test
• People with a severe, uncontrolled infection such as blood poisoning (sepsis) or multiple organ failure, or uncontrolled fever
• People with a confirmed, uncontrolled fungal infection shown by blood tests and cultures
• People who have had a heart attack, unstable chest pain (angina), stroke, or a brief stroke-like episode (TIA) in the 3 months before this stage
• People who are on kidney dialysis (either haemodialysis or peritoneal dialysis)

Who might be able to join — later stage (R4-DEX randomisation, after induction or salvage treatment):

• People already enrolled in this trial at diagnosis
• People whose AML has gone into first remission after initial treatment or one round of salvage treatment, confirmed within the 15 days before this stage
• People whose AML is classified as favourable or intermediate risk under the trial's risk system
• People whose general health meets a certain minimum level (ECOG score of 2 or below)
• People whose kidney and liver blood test results are within acceptable ranges for this stage
• People who have signed the informed consent form specifically for this part of the trial

Who may not be able to join — R4-DEX stage:

• People with a severe, uncontrolled infection such as blood poisoning, multiple organ failure, or uncontrolled fever
• People with a confirmed, uncontrolled fungal infection shown by blood tests and cultures
• People who have had a heart attack, unstable chest pain, stroke, or a brief stroke-like episode in the 3 months before this stage
• People who are on kidney dialysis (either haemodialysis or peritoneal dialysis)

Who might be able to join — later stage (R4-VEN randomisation, after induction or salvage treatment):

• Adults aged 18 to 60 years old at the time of joining the main trial
• People diagnosed with AML (de novo, arising from MDS, or therapy-related) who are already enrolled in this trial
• People whose AML has gone into first remission after one or two rounds of initial chemotherapy under the trial protocol and who are planned to receive further consolidation treatment
• People whose AML is classified as favourable or intermediate risk under the trial's risk system
• People whose general health meets a certain minimum level (ECOG score of 2 or below)
• People whose heart pumping function (LVEF) is at least 40%, measured by a specific heart scan
• People whose kidney and liver blood test results are within acceptable ranges for this stage
• People who do not have an uncontrolled infection
• Women of childbearing potential who agree to use effective contraception throughout the study and for 3 months after treatment ends
• People who have signed the written informed consent form

Who may not be able to join — R4-VEN stage:

• People classified as unfavourable risk under the trial's risk system
• People with a specific AML subtype (acute promyelocytic leukaemia or CBF AML)
• People whose AML developed from a prior myeloproliferative disorder or who have Philadelphia chromosome-positive AML
• People whose AML has not gone into remission after a maximum of two chemotherapy cycles
• People with a serious physical or mental condition that would make the planned treatments unsafe
• People who have had another cancer that was not under control for at least 2 years (certain skin cancers and early-stage cervical changes are exceptions)
• Women with a positive pregnancy test
• Women who are breastfeeding
• People with a severe, uncontrolled infection such as blood poisoning, multiple organ failure, or uncontrolled fever
• People with a confirmed, uncontrolled fungal infection shown by blood tests and cultures
• People who have previously been treated with a medication called venetoclax
• People known to have hepatitis B with a detectable viral load
• People known to be HIV positive
• People with a known allergy to any of the study medications
• People who have had a heart attack, unstable chest pain, stroke, or a brief stroke-like episode in the 3 months before this stage
• People who are on kidney dialysis (either haemodialysis or peritoneal dialysis)
• People who are taking certain other medications (called CYP3A4 inhibitors) that cannot be stopped during treatment — this applies in a specific phase of the trial (confirm details with trial site)

Who might be able to join — R3 randomisation (before stem cell transplant):

• People already enrolled in this trial at diagnosis
• People whose AML has gone into first remission and who are classified as intermediate risk under the trial's system — this includes specific situations such as those who initially had a favourable-risk AML but showed poor response on a specialised molecular monitoring test, or those who needed two rounds of treatment to achieve remission, or others with intermediate risk features (confirm with trial site)
• People who do not have another active cancer spreading in the body (certain skin cancers and early-stage cervical changes are exceptions)
• People whose general health meets a certain minimum level (ECOG score of 3 or below) and who do not have a severe, uncontrolled infection
• Women of childbearing age who agree to use effective contraception
• People who are enrolled in a social security or universal health coverage scheme
• People who have read, understood, and signed the informed consent form for this stage

Who may not be able to join — R3 stage:

• People whose AML has not gone into remission after initial and/or salvage treatment
• People whose AML is classified as either favourable risk or unfavourable risk (this stage is only for those classified as intermediate risk)
• People with a serious physical or psychiatric condition unrelated to AML that would make a stem cell transplant unsafe
• People who, for personal, social, or geographic reasons, would not be able to attend regular medical check-ups
• People with a severe, uncontrolled infection at the time of joining this stage
• People who test positive for HIV-1, HIV-2, HTLV-1, HTLV-2, or who have an active hepatitis B or C infection
• Women who are pregnant or currently breastfeeding
• People who are legally unable to give their own consent (for example, those under legal guardianship or court protection)
• People covered under a specific French State Medical Assistance scheme (AME) (confirm with trial site)

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