Phase 2 Leukaemia Trial, Recruiting NCT06511882 Sponsor: H. Lee Moffitt Cancer Center and Research Institute Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT06511882
Recruiting Phase 2

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:

  • Adults aged 18 or older at the time of agreeing to take part
  • People who have been diagnosed with a type of blood cancer called Acute Myeloid Leukemia (AML), specifically a non-M3 subtype, as defined by World Health Organization (WHO) 2016 guidelines
  • People whose general health and ability to carry out daily activities meets a certain minimum level (confirm with trial site)
  • People who are currently being treated with a combination of medications called HMA (either azacitidine or decitabine) plus venetoclax as their first treatment for AML, and whose disease has gone into remission with no detectable cancer cells found by a sensitive test called Multiparameter Flow Cytometry
  • People who started their current treatment within the last 12 months
  • People who are not suitable for, or who have chosen not to have, a stem cell transplant from a donor
  • People who are willing and able to sign a consent form agreeing to take part
  • People who are able to follow the visit schedule and other requirements of the study
  • People who are able to provide bone marrow samples (taken by a procedure called a bone marrow aspirate and biopsy) during the screening process

Who may not be able to join:

  • People who have received other chemotherapy or experimental (not commercially available) cancer treatments within the past 28 days or within 5 half-lives of those treatments (note: a medication called hydroxyurea taken before achieving remission is allowed)
  • People with a serious or uncontrolled medical condition, such as an active infection, heart failure, unstable chest pain, irregular heart rhythms, or a mental health or social situation that could make it difficult to safely participate (note: well-controlled infections or other conditions being managed with long-term treatment may still be allowed)
  • People whose cancer was found to have a specific gene change called a TP53 mutation at the time of their original diagnosis
  • People whose AML has spread outside the bone marrow — for example, to the nervous system, formed tumours in other parts of the body, or affected the skin — and who need treatment directed at those areas at the time of enrolment
  • People who are pregnant

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 28 July 2026
Phase 2: approximately ~30% 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: Onyee Chan, MD, Moffitt Cancer Center

Phone: 813-745-6138

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 2
Registry
ClinicalTrials.gov
Start date
7 November 2024
Est. completion
1 October 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Rates of Complete Response (CR)/Complete Response with incomplete hematologic recovery (CRi)

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: 28 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