Phase 2 Leukaemia Trial, Recruiting NCT05657639 Sponsor: The First Affiliated Hospital of Soochow University Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT05657639
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 between 16 and 70 years old
  • People who have been diagnosed with acute myeloid leukaemia (AML) that has come back after treatment or has not responded to treatment
  • People whose AML has not responded to at least 2 rounds of standard intensive chemotherapy, or where a specific bone marrow measurement showed less than 50% but more than 20% reduction in leukaemia cells after 1 round of treatment
  • People whose AML has come back, shown by leukaemia cells reappearing in the blood, 5% or more blast cells found in the bone marrow without another explanation, or leukaemia returning outside the bone marrow
  • People who are generally well enough to carry out light daily activities (based on a standard health scoring system called ECOG, with a score of 0 or 1)
  • People expected to live for at least 12 weeks
  • People without serious problems affecting the heart, lungs, liver, or kidneys
  • People who are able to understand the study and agree in writing to take part

Who may not be able to join:

  • People who have had an allergic reaction to the study drug or to chemically similar drugs
  • People who are pregnant, breastfeeding, or women of childbearing age who are not willing to use effective contraception during the study
  • People who currently have an active infection
  • People who currently have active bleeding
  • People who have had a blood clot, embolism, or brain bleed, or certain other serious conditions, within the past year
  • People with a mental health disorder or other conditions that may affect participation (confirm with trial site)
  • People with significantly abnormal liver function test results or reduced kidney function based on specific blood test measurements
  • People with a history of certain heart problems, including a prolonged QTc interval on an ECG, a type of fast heart rhythm, irregular heart rhythm, certain degrees of heart block, a heart attack within the past year, heart failure, or coronary artery disease requiring medication
  • People whose leukaemia has returned after a bone marrow or stem cell transplant from a donor
  • People with a history of drug abuse or long-term heavy alcohol use that may affect study results
  • People who have previously received an organ transplant
  • People considered unsuitable for the study by the treating doctor

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 14 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

Phone: 008651267781139

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 Soochow University
Registry
ClinicalTrials.gov
Start date
1 October 2022
Est. completion
1 October 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Overall response rate (ORR)

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: 14 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