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Phase 2 Leukaemia Trial, Recruiting
NCT06284486
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:
- You are 12 years old or older and weigh at least 45 kg (about 99 lbs).
- You are well enough to carry out basic daily activities, based on an age-appropriate health performance scale (confirm with trial site for exact scoring).
- You have been diagnosed with a specific type of acute myeloid leukemia (AML) involving certain gene changes known as NPM1mt, KMT2Ar, or NUP98r.
- A recent bone marrow test shows your leukemia is in remission (very low blast cell levels), but a sensitive test has detected small remaining signs of leukemia (called MRD) at a level of 0.1% or more.
- Your leukemia is not actively spreading outside the bone marrow.
- Your heart is pumping adequately, with an ejection fraction above 40%.
- Your liver is functioning at an acceptable level based on blood tests.
- Your kidneys are functioning at an acceptable level based on blood tests.
- You are able to swallow pills.
- You or your parent/guardian is willing and able to give informed consent to participate.
- You agree to use reliable contraception during the study and for at least 3 months after the last treatment (applies to both women who could become pregnant and men who are not sterile).
Who may not be able to join:
- You have previously been treated with a type of drug called a menin inhibitor.
- You are expected to continue benefiting from standard leukemia treatments (such as intensive chemotherapy or certain drug combinations).
- You are expected to be able to have a stem cell transplant within the next 30 days.
- You have another serious uncontrolled medical condition, abnormal lab results, or mental health condition that could put you at risk during the study.
- You are currently receiving other chemotherapy or anti-leukemia treatments (some limited exceptions may apply — confirm with trial site).
- You have a serious stomach or digestive condition that could prevent you from properly absorbing oral medication.
- You are currently being treated for another active cancer.
- You have a known active hepatitis B, hepatitis C, or HIV infection.
- You are currently pregnant or breastfeeding.
- You have an active infection that is not under control.
- You have had a heart attack, severe heart problems, stroke, or related serious cardiovascular event within the past 6 months.
- Your heart's electrical activity (measured by an ECG) shows a reading above a certain threshold (QTc above 450 ms for males or 470 ms for females) (confirm with trial site).
- Your doctor believes participation would not be in your best interest or could affect the study results.
- You have leukemia that is actively affecting your brain or spinal fluid.
- You are currently taking immune-suppressing medications following a previous stem cell transplant, unless you have been off them for a required period of time (confirm with trial site for details).
- You have moderate to severe active graft-versus-host disease (a complication that can follow a stem cell transplant) (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.
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
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Trial details
Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
23 September 2024
Est. completion
30 December 2026
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Safety and adverse events (AEs)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 5 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.