Phase 1 Leukaemia Trial, Recruiting NCT05627232 Sponsor: Thomas Jefferson University Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT05627232
Recruiting Phase 1

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 willing and able to sign a consent form and follow all study requirements for the full duration of the trial
  • You are 18 years of age or older
  • You have been diagnosed with acute myeloid leukemia (a type of blood cancer) that has been confirmed by a tissue sample, and it has come back or stopped responding to at least one previous treatment
  • You have had a bone marrow test within 28 days before screening, or you may be able to skip this if enough cancer cells are already visible in your blood (confirm with trial site)
  • If you received a previous experimental treatment, it must have been at least 2 weeks before joining, and any side effects must have mostly cleared up (except hair loss)
  • You are well enough to carry out some daily activities — not completely bedridden (confirm with trial site)
  • Your doctor expects you to live for at least 4 weeks
  • You are able to swallow and take medication by mouth
  • Your kidneys are working well enough to meet the trial's requirements (confirm with trial site)
  • Your liver function is within an acceptable range (confirm with trial site)
  • If you are a woman who could become pregnant, you must have a negative pregnancy test

Who may not be able to join:

  • You have a specific subtype of leukemia called acute promyelocytic leukemia
  • You are currently receiving chemotherapy (except for a drug called hydroxyurea; certain spinal-delivered drugs are allowed)
  • Joining the trial would cause your total lifetime dose of a specific heart-related chemotherapy drug (daunorubicin) to exceed safe limits, especially if you have previously had radiation to your chest area
  • There are signs that the leukemia has spread to your brain or spinal fluid and is currently active
  • You are currently receiving certain growth-stimulating drugs (except erythropoietin, which helps with red blood cells)
  • You have another active cancer, with some exceptions such as certain skin cancers, early-stage cervical changes, or a low-risk form of prostate cancer that has been removed (confirm with trial site)
  • You have unstable heart disease or an uncontrolled irregular heartbeat
  • You have another serious illness that your doctor believes would make intensive treatment unsafe for you
  • You are currently pregnant or breastfeeding
  • You have a known allergy to any ingredient in the study treatment
  • Any other condition that could put you at extra risk or prevent you from completing the study (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 5 July 2026
Phase 1: approximately ~10% 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: Gina Keiffer, MD, Thomas Jefferson University

Phone: 215-955-2929

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 1
Sponsor
Thomas Jefferson University
Registry
ClinicalTrials.gov
Start date
28 August 2023
Est. completion
1 January 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of grade >= 3 non-hematologic dose limiting toxicities

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: 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.

View original record on ClinicalTrials.gov