Phase 2 Leukaemia Trial, Recruiting NCT07249346 Sponsor: Hannah Choe, MD Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT07249346
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 who are 18 years of age or older at the time of joining the trial.
  • People who are scheduled to receive a stem cell transplant from a donor (called an allogeneic transplant) for acute leukemia, with no leukemia cells circulating in the blood and fewer than 5% abnormal cells in the bone marrow.
  • People who are scheduled to receive a donor stem cell transplant for a bone marrow disorder called myelodysplasia or chronic myelomonocytic leukemia, with no abnormal cells in the blood and fewer than 10% abnormal cells in the bone marrow.
  • People whose transplant plan includes a high-intensity preparatory treatment (called myeloablative conditioning).
  • People who have a suitable matched sibling or unrelated stem cell donor, where the donor's tissue type closely matches the patient's (specific matching levels apply — confirm with trial site), and the donor is willing and medically cleared to donate.
  • People whose heart is pumping at least 45% of its normal capacity (based on a heart function test).
  • People whose kidneys are filtering blood at a rate above a certain level (confirm exact threshold with trial site).
  • People whose lungs are functioning at or above a minimum level on breathing tests (confirm exact thresholds with trial site).
  • People whose liver test results are within acceptable ranges (confirm exact values with trial site).
  • People who are able to carry out normal daily activities to a reasonable degree, based on a standard performance scale (confirm exact score requirement with trial site).
  • Female patients who are not post-menopausal for at least one year or surgically sterilised must agree to use two effective forms of contraception, or completely abstain from heterosexual intercourse, from signing the consent form through 12 months after transplant.
  • Male patients must agree to use effective barrier contraception or abstain from heterosexual intercourse from signing the consent form through 12 months after transplant, even if surgically sterilised.
  • People whose plans for any ongoing medication after transplant are disclosed at enrolment, and who plan to use only permitted maintenance medications if any (certain targeted therapies are allowed — confirm which ones with trial site).
  • People who are willing and able to give voluntary written consent to participate, understanding they may withdraw at any time without affecting their future care.

Who may not be able to join:

  • People who have previously had a donor stem cell transplant.
  • People whose cancer has spread to the central nervous system (brain or spinal cord).
  • People whose acute myeloid leukemia developed from certain other blood disorders called myeloproliferative neoplasms or overlap syndromes (confirm specific diagnosis with trial site, as some cases may still be eligible).
  • People who have an active bacterial, viral, or fungal infection that is not responding to treatment at the time of enrolment.
  • People with active or inadequately treated tuberculosis (TB).
  • People who are HIV-positive with a detectable level of virus in their blood (those with an undetectable viral load on treatment may still be considered eligible — confirm with trial site).
  • People with uncontrolled hepatitis B or hepatitis C virus (certain controlled cases with treatment may still be considered eligible — confirm with trial site).
  • People who have had a blood clot in a vein or artery (such as a deep vein clot, pulmonary embolism, stroke, or heart attack) within the past six months, or who have severe or uncontrolled heart conditions (confirm specific conditions with trial site). Note: blood clots caused by a medical catheter are not automatically disqualifying.
  • People who are pregnant or breastfeeding.
  • People with a serious medical or mental health condition that is likely to make participation in the trial difficult.
  • People who have had another cancer in the past, with some exceptions: certain skin cancers and previously treated cervical changes in situ may be allowed, and cancers treated with curative intent five or more years ago may be permitted — cases treated more recently require review and approval by the trial team (confirm with trial site).
  • People whose transplant plan includes certain immune-suppressing medications called ATG or alemtuzumab.
  • People whose plan includes a procedure called prophylactic donor leukocyte infusion after transplant.
  • People who have previously taken a medication called ruxolitinib.
  • People who have used certain immune checkpoint inhibitor medications within the six months before starting the preparatory treatment (confirm specific drug types with trial site).
  • People with a hereditary heart condition called congenital Long QT syndrome.

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 26 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: Hannah Choe, MD, Ohio State University Comprehensive Cancer Center

Phone: 1-800-293-5066

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
Sponsor
Hannah Choe, MD
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Severe acute GVHD-free Survival (SGFS)

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: 26 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