Phase 2 Leukaemia Trial, Recruiting NCT06316960 Sponsor: Children's Hospital of Soochow University Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT06316960
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 of any gender
  • People under 18 years of age
  • People who have been diagnosed with acute myeloid leukemia (AML), a type of blood cancer, based on 2022 medical classification guidelines
  • People whose AML has a specific genetic feature — either t(8;21)/RUNX1::RUNX1T1 or inv(16)/t(16;16)/CBFβ::MYH11 (confirm with trial site)
  • People whose AML also has a specific gene change called a KIT mutation
  • People whose AML did not respond to initial treatment (meaning the cancer did not go into remission after the first round of chemotherapy)
  • People whose AML came back after previously going into remission following further treatment or a transplant, confirmed by specific genetic testing
  • People who do not have an active infection at the time of joining
  • People whose liver and kidney are working well enough to meet specific blood test levels (confirm with trial site)
  • People who are fairly active and able to carry out daily activities (a medical scoring system called ECOG rates this as less than 2)
  • People whose expected survival is more than 12 weeks
  • People who are able to understand the study and are willing to sign a consent form agreeing to take part

Who may not be able to join:

  • People who have previously been treated with a drug called avapritinib
  • People who are currently receiving other targeted AML treatments at the same time, such as dasatinib, sorafenib, gilteritinib, or venetoclax
  • People who have an active, uncontrolled infection (bacterial, fungal, or viral)
  • People who have serious ongoing problems with the heart, liver, or kidneys, such as heart failure or a recent heart attack
  • People who have another type of cancer that is currently being treated
  • People who are already taking part in another clinical trial that involves a treatment or intervention
  • People whom the trial researchers determine are not suitable for the study for other reasons

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: Shaoyan Hu, MD, PhD, Children 's Hospital of Soochow University

Phone: +86-13771870462

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
Children's Hospital of Soochow University
Registry
ClinicalTrials.gov
Start date
1 March 2024
Est. completion
1 March 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Composite remission rate (CRc)

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