Phase 2 Leukaemia Trial, Recruiting NCT06811233 Sponsor: M.D. Anderson Cancer Center Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT06811233
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:

  • People aged 18 or older who are able to provide signed consent (or have a legally authorised representative do so on their behalf).
  • People who have been diagnosed with newly diagnosed or previously untreated acute myeloid leukaemia (AML) — a type of blood cancer — that is classified as intermediate or high risk, including certain subtypes such as AML with a specific chromosome abnormality called Ph+ (Philadelphia chromosome positive).
  • People diagnosed with a blood cancer that has progressed into a "blast phase," including certain bone marrow disorders such as myeloproliferative neoplasms (MPNs) or chronic myeloid leukaemia (CML) that have transformed into an advanced stage.
  • People whose AML developed as a result of a previous blood or bone marrow condition (such as MDS, MPN, or aplastic anaemia), or as a result of previous cancer treatment — with some exceptions (confirm with trial site).
  • People who have already started standard (non-experimental) treatment for AML, as long as they are still within the first two cycles of treatment and have not yet achieved complete remission.
  • People whose general health and ability to carry out daily activities meets a level rated 2 or below on a standard medical scale (meaning they are able to care for themselves but may not be able to do heavy physical work).
  • People whose kidney function, liver function, and bilirubin (a liver-related substance) blood test results fall within specific acceptable ranges, unless those results are affected by the leukaemia itself.
  • Women who could become pregnant must have a negative pregnancy test within 14 days of joining and must agree to use at least one highly effective form of contraception (such as an IUD, hormonal birth control, tubal ligation, or a partner who has had a vasectomy). Men must agree to use a condom if their partner could become pregnant, and agree not to try to father a child during the trial.
  • People who have AML that has spread outside the bone marrow, as long as that spread can be measured and monitored during the trial.

Who may not be able to join:

  • People who are pregnant or currently breastfeeding. Anyone who becomes pregnant during the trial should inform their treating doctor immediately.
  • People with serious uncontrolled health conditions, including uncontrolled active infection, heart failure, unstable chest pain (angina), or mental health or personal circumstances that the trial doctor believes would make safe participation too risky or make it difficult to follow the trial requirements.
  • People diagnosed with a specific subtype of AML called acute promyelocytic leukaemia (APL).
  • People who have previously been treated with a medicine called venetoclax and did not respond to it or stopped responding.
  • People whose secondary AML involves specific chromosome changes known as CBF — specifically t(8;21) or inv(16) (confirm with trial site).

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 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: Maro Ohanian, DO, M.D. Anderson Cancer Center

Phone: (713) 792-2631

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
8 May 2025
Est. completion
31 August 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety and Adverse Events (AEs)

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