Phase 2 Leukaemia Trial, Recruiting NCT07259707 Sponsor: First Affiliated Hospital of Zhejiang University Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT07259707
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:

  • The person joining (or their legal representative) must sign a consent form showing they understand the study and agree to take part, before any study procedures begin.
  • Adults aged 18 to 60 years old at the time of screening (or the legal adult age in their country, whichever is higher).
  • People who have been newly diagnosed with a specific type of blood cancer called acute myeloid leukemia (AML) that has a particular gene change called FLT3-ITD, classified as intermediate risk under a standard medical guideline called ELN 2022.
  • People whose general health and organ function (including liver, kidneys, and heart) are within acceptable ranges, as measured by blood tests and a heart scan within a set timeframe before joining.

Who may not be able to join:

  • People diagnosed with certain specific types of AML, including a type called acute promyelocytic leukemia (APL), a type linked to a gene change called BCR-ABL, or AML that developed as a result of previous chemotherapy or radiation treatment.
  • People with a history of another cancer, unless it was a non-serious skin condition, a fully cured early-stage cancer, or a solid tumour that was treated and has shown no signs of returning for at least 2 years.
  • People whose overall health or organ function means they are considered unsuitable for intensive chemotherapy, based on factors such as heart problems, lung problems, kidney problems, liver problems, or other serious health conditions.
  • People with an active infection (fungal, bacterial, or viral) that is not under control.
  • People with a known active liver disease such as active hepatitis B or C, or a known history of HIV infection.
  • People with a known allergy to any ingredient in the study medication (gilteritinib tablets).
  • People who are pregnant or breastfeeding.
  • People 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

Phone: +8613867439726

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
First Affiliated Hospital of Zhejiang University
Registry
ClinicalTrials.gov
Start date
25 January 2026
Est. completion
31 December 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Composite Complete Remission (CRc) Rate after 2 induction cycles

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