Leukaemia Trial, Recruiting NCT06458257 Sponsor: Ruijin Hospital Condition: Leukaemia
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Leukaemia Trial, Recruiting

NCT06458257
Recruiting Not Applicable

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 AML (a type of blood cancer) that has a specific gene change called a CEBPA mutation, confirmed by molecular testing.
  • People whose AML has certain high-risk features, such as a protein called CD7 on their cancer cells, a WT1 gene mutation, a specific type of CEBPA mutation, a complex chromosome pattern, or detectable traces of leukemia remaining after two rounds of chemotherapy (measured by specialised lab tests).
  • People whose diagnosis has been confirmed through detailed testing (covering cell type, chromosome, molecular, and immune markers), and where other related blood conditions such as MDS or treatment-related AML have been ruled out.
  • People aged 18 to 64 years old.
  • People whose liver and kidney function fall within acceptable ranges (specific blood test values within defined limits).
  • People with normal heart function, confirmed by an echocardiogram showing the heart pumping at least 50% efficiency, and classified as Class I or II under standard heart function guidelines.
  • People with a general health and activity level rated 0, 1, or 2 on a standard medical scale (ECOG score), meaning they are reasonably active and able to care for themselves.
  • People whose white blood cell count was below a certain level at diagnosis and who have not received any chemotherapy other than a drug called hydroxyurea before starting treatment in this trial.
  • People whose white blood cell count was at or above a certain level at diagnosis, for whom limited prior treatment with cytarabine or hydroxyurea before starting the trial is allowed.
  • Women who are not currently pregnant or breastfeeding.
  • Women who could potentially become pregnant must have a negative pregnancy blood test (hCG) before joining.
  • People (or their family member, where applicable) who have signed an informed consent form agreeing to take part.

Who may not be able to join:

  • People whose AML developed from another blood condition called MDS, or whose AML was caused by prior cancer treatment, or who have a mixed-cell type of leukemia, or who have leukemia that has spread to the brain or to areas outside the bone marrow.
  • People whose AML has already relapsed (come back after treatment).
  • People who are known to be allergic to, or who have medical reasons to avoid, any of the drugs used in this trial.
  • People whose liver or kidney function test results fall outside the acceptable ranges set for this trial.
  • People with significant heart problems, including a heart pumping rate below 50%, heart failure rated Class III or IV, fluid around the heart above a certain severity level, a heart attack in the past six months, or an abnormal heart rhythm reading on an ECG.
  • People with significant lung problems, including fluid on or around the lungs above a certain severity level.
  • People who currently have another type of cancer in another organ.
  • People with an active infection from Hepatitis A, B, or C, active tuberculosis, or who test positive for HIV.
  • People who have another blood disorder alongside their leukemia, including abnormal blood clotting that is unrelated to the leukemia.
  • People who are unable to understand or follow the study's instructions and requirements.
  • People who are currently participating in another clinical trial, or who have any other condition that would prevent safe participation in this study.

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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
19 October 2024
Est. completion
1 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

disease-free-survival; The relation of CEBPA Mutant AML genetics subgroup with MRD negativity rate after chemotherapy and DFS after transplantation

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