Phase 2 Leukaemia Trial, Recruiting NCT06229912 Sponsor: M.D. Anderson Cancer Center Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT06229912
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 12 or older who weigh at least 40 kg (about 88 pounds)
  • People whose general health and ability to carry out daily activities meets a certain minimum level (confirm with trial site)
  • People who have acute leukemia (of myeloid, lymphoid, or mixed type) that has come back or stopped responding to treatment, and whose leukemia has specific genetic changes linked to a group of genes called HOX genes — the exact genetic changes considered eligible are listed in the trial criteria (confirm with trial site)
  • People whose white blood cell count is below 25,000 per microlitre at the time of joining — treatment to lower the count beforehand may be allowed
  • People whose heart is pumping at least 40% of its normal capacity
  • People whose liver is functioning at an adequate level, based on specific blood test results (confirm with trial site)
  • People whose kidneys are functioning at an adequate level, based on a kidney filtration rate of at least 60 mL/min
  • People (or their parent or guardian, if applicable) who are willing and able to give informed consent to participate
  • People who have waited an appropriate amount of time since their last treatment before starting the trial — generally at least 14 days or five half-lives of the prior treatment, with some exceptions allowed for rapidly progressing disease
  • People who are able and willing to use adequate contraception during the trial and for at least 3 months after the last treatment

Who may not be able to join:

  • People who have another serious uncontrolled medical condition, significant abnormal test results, or a mental health condition that would make participation too risky
  • People who are receiving other chemotherapy or anti-leukaemia treatments at the same time — though some limited exceptions apply, such as certain treatments for leukemia affecting the brain and spinal fluid, or short-term treatments for rapidly growing disease (confirm with trial site)
  • People who have a severe gut or metabolic condition that could prevent the oral study medication from being properly absorbed
  • People who have another active cancer that is currently being treated
  • People with a known active hepatitis B, hepatitis C, or HIV infection
  • People who are pregnant or breastfeeding
  • People who have an active, uncontrolled infection at the time of joining
  • People who have had a heart attack, unstable chest pain, significant heart failure, life-threatening irregular heartbeat, stroke, or mini-stroke within the 6 months before joining the trial
  • People whose heart's electrical activity (measured by an ECG) shows a reading above a certain threshold — above 450 milliseconds for males and above 470 milliseconds for females
  • People who have a history or current condition that, in the investigator's judgement, could affect the trial results, interfere with full participation, or would not be in the person's best interest
  • People who have leukemia that is currently active in the brain or spinal fluid
  • People who have had a stem cell transplant and are still taking immune-suppressing medications — a minimum waiting period off these medications is required before joining (confirm with trial site)
  • People who have moderate to severe graft-versus-host disease (a complication that can occur after a stem cell transplant) that is not well controlled

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 20 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: Ghayas Issa, MD, M.D. Anderson Cancer Center

Phone: (713) 745-6798

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
4 June 2024
Est. completion
1 December 2026

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: 20 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