Phase 1 Leukaemia Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been newly diagnosed with acute myeloid leukaemia (AML), or certain higher-risk blood/bone marrow conditions (higher-risk MDS or a specific type of CMML) — the trial team will confirm whether these related conditions qualify on a case-by-case basis
- People who have previously received certain treatments (hypomethylating agents, with or without a BCL2 inhibitor) for MDS or AML may also be considered, at the trial doctor's discretion
- People aged 18 to 75 years old
- People who are reasonably active and able to care for themselves, with limited restrictions on daily activity (as measured by a standard medical scale called ECOG, score of 0, 1, or 2)
- People whose kidneys are working well enough, based on a standard blood test result (confirm with trial site for exact values)
- People whose liver is functioning well enough, based on standard blood test results — some exceptions may apply if liver changes are caused by the leukaemia itself or a specific inherited condition called Gilbert's disease (confirm with trial site)
- People who are able to understand the trial information and sign a consent form
- Male participants who agree to use contraception and avoid sperm donation from the start of the trial until 90 days after the last dose of the study drug
Who may not be able to join:
- People whose leukaemia involves a specific genetic change called t(15;17), or who have a type of leukaemia known as acute promyelocytic leukaemia (APL/M3-AML)
- People whose leukaemia has spread to the central nervous system (the brain and spinal cord)
- People with moderate to severe heart failure, or whose heart pumping function is below a certain level on a heart scan
- People who have had a heart attack in the last 6 months, or who have unstable or uncontrolled chest pain, or a history of serious uncontrolled heart rhythm problems
- People with uncontrolled HIV, or active Hepatitis B or C infection
- People who have difficulty swallowing or absorbing medication through the gut, such as those with short-gut syndrome or similar conditions, as some study drugs are taken by mouth
- People with any other significant medical or mental health condition that the trial doctor believes would make participation unsafe or unsuitable
- People whose white blood cell count is too high (above a certain level) — note that specific medications may be used beforehand to bring this count down to an acceptable level (confirm with trial site)
- Women who are pregnant (confirmed by a urine test), breastfeeding, or women who could become pregnant but are not willing or able to use an effective method of contraception (such as hormonal contraception, an IUD, or a double barrier method like a condom with spermicide)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Ioannis Mantzaris, MD, Montefiore Medical Center
Phone: 718-920-4826
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Frequency and Severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs); Frequency and Severity of AEs and SAEs by Age Group; Frequency and Severity of AEs and SAEs by Dose Level; Rate of Non-Hematologic Dose Limiting Toxicities (DLTs); Rate of Hematologic Dose Limiting Toxicities (DLTs); The Number/Percentage of Patients with Dose Modifications; Maximum tolerated dose of Venetoclax in combination with Daunorubicin and Cytarabine; Maximum tolerated dose of Venetoclax in combination with high dose Cytarabine
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.