Phase 3 Leukaemia Trial, Recruiting NCT05586074 Sponsor: Sunshine Lake Pharma Co., Ltd. Condition: Leukaemia
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Phase 3 Leukaemia Trial, Recruiting

NCT05586074
Recruiting Phase 3

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 are 18 years of age or older at the time of joining the trial
  • People who have been diagnosed with a specific type of blood cancer called acute myeloid leukemia (AML), either as a primary condition or developed from a prior blood disorder called myelodysplastic syndrome (MDS), as classified by World Health Organization (WHO) standards
  • People whose AML either did not respond to their first round of treatment, or came back after their first round of treatment (with or without a stem cell transplant)
  • People who test positive for a specific gene change called a FLT3 mutation, confirmed by a central laboratory using a bone marrow or blood sample
  • People who have a general health and activity level rated at 0, 1, or 2 on a standard medical scale (meaning able to carry out daily activities with little to no limitation)
  • People for whom the treating doctor considers a specific type of follow-up chemotherapy (called salvage chemotherapy) to be appropriate

Who may not be able to join:

  • People who have previously been treated with any medication that targets the FLT3 mutation (known as FLT3 inhibitors)
  • People whose AML has returned or stopped responding after more than one round of treatment
  • People who currently have an active infection that is not under control
  • People who are known to have HIV (human immunodeficiency virus)
  • People who have any other health condition that, in the treating doctor's judgement, would make participation in the trial unsuitable

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 15 July 2026
Phase 3: approximately ~65% 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: Jie Jin, MD, PhD, First Affiliated Hospital of Zhejiang University

Phone: 86 13692244182

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 3
Sponsor
Sunshine Lake Pharma Co., Ltd.
Registry
ClinicalTrials.gov
Start date
3 March 2023
Est. completion
30 November 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

OS; CR/CRh 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: 15 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