Phase 2 Leukaemia Trial, Recruiting NCT05603884 Sponsor: The First Affiliated Hospital of Xiamen University Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT05603884
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 have been diagnosed with acute myeloid leukemia (a type of blood cancer), confirmed by laboratory testing, who have not yet received treatment for it, and whose doctors consider standard intensive chemotherapy unsuitable due to age, other health conditions, or personal choice.
  • People aged 60 or older, of any sex, with a life expectancy of more than 3 months.
  • People whose kidneys are functioning at an adequate level (creatinine clearance of 30 mL/min or above).
  • People whose liver function test results are within an acceptable range, as defined by the trial criteria (confirm with trial site).
  • People with a general health and activity level rated at 2 or below on a standard medical scale, meaning they are able to care for themselves even if unable to do strenuous activity.
  • People who are able to understand the trial information and agree to take part voluntarily.

Who may not be able to join:

  • People whose blood cancer is a specific subtype called acute promyelocytic leukemia (APL), or whose cancer has certain low-risk genetic features.
  • People whose leukemia has spread to the central nervous system (brain and spinal cord).
  • People with a history of certain blood or bone marrow conditions, including myelofibrosis, essential thrombocythemia, polycythemia vera, or chronic myeloid leukemia, or a specific genetic change called BCR-ABL1.
  • People who are HIV positive, or who have an active hepatitis B or hepatitis C infection confirmed by blood tests.
  • People with serious ongoing conditions affecting the lungs (requiring continuous oxygen), kidneys, nervous system, mental health, hormone systems, immune system, liver, or heart and blood vessels.
  • People with conditions that prevent them from absorbing or swallowing oral medication.
  • People with certain heart-related issues, including an abnormal heart rhythm reading on an ECG, irregular heartbeat, a heart attack within the past year, heart failure, or coronary heart disease requiring ongoing medication.
  • People with a serious, uncontrolled active infection.
  • People who have had another cancer within the past 2 years, with some exceptions — such as certain early-stage cervical or breast cancers, basal cell skin cancer, or localised squamous cell skin cancer that have been adequately treated.
  • People with a white blood cell count above a certain level, unless this has been brought down with medication or a medical procedure (confirm with trial site).
  • People with a mental health condition that would make participation in the trial difficult.
  • People who have previously received certain treatments, including hypomethylating agents, venetoclax, chemotherapy for a related blood condition called myelodysplastic syndrome, or a solid organ transplant.
  • People whom the trial doctor considers unsuitable for any other reason.

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: Bing Xu, M.D., The First Affiliated Hospital of Xiamen University

Phone: +865922137255

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
The First Affiliated Hospital of Xiamen University
Registry
ClinicalTrials.gov
Start date
1 December 2022
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Complete remission (CR) rate

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