Phase 1 Leukaemia Trial, Recruiting NCT05342584 Sponsor: Montefiore Medical Center Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT05342584
Recruiting Phase 1

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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

Status
Recruiting
Phase
Phase 1
Sponsor
Montefiore Medical Center
Registry
ClinicalTrials.gov
Start date
25 May 2022
Est. completion
1 December 2028

Where this trial is recruiting

🇺🇸 United States

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?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov