Phase 2 Leukaemia Trial, Recruiting NCT05445154 Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT05445154
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 who have been newly diagnosed with acute myeloid leukemia (AML) for the first time, with no prior treatment, where more than 20% of bone marrow cells are blast (abnormal) cells, as confirmed before joining the trial
  • People aged 18 or older but under 60 years old
  • People whose AML tests positive for a specific gene change called a FLT3 mutation, confirmed by the trial's central laboratory
  • People who are reasonably able to carry out daily activities (a medical rating scale called ECOG will be used to assess this — a score of 2 or less is required; confirm with trial site)
  • People whose liver and kidney function blood test results fall within acceptable ranges set by the trial (confirm specific values with trial site)
  • People who are able to swallow and take the study drug by mouth

Who may not be able to join:

  • People diagnosed with a specific subtype of leukemia called acute promyelocytic leukemia (APL), or a type of leukemia related to a gene change called BCR-ABL
  • People who currently have another active cancer diagnosis other than AML
  • People whose AML developed as a result of previous radiation therapy or chemotherapy for another cancer
  • People whose AML has spread to the brain or spinal cord (central nervous system)
  • People who have persistently low levels of potassium or magnesium in their blood that are difficult to correct with treatment and have occurred repeatedly
  • People who currently have a significant complication related to a previous bone marrow or stem cell transplant (confirm details with trial site)
  • People with a previous history of other cancers
  • People with serious blood clotting disorders, such as DIC (a condition where clotting occurs throughout the body), haemophilia A, haemophilia B, or von Willebrand disease
  • People who have recently had major surgery on a major organ, or who have not yet fully recovered from such surgery before joining the trial (confirm definition of "major surgery" with trial site)
  • People who have already received treatment specifically for AML — with limited exceptions including emergency procedures to reduce white blood cell counts, a short course of a drug called hydroxyurea in an emergency, growth factor or cell support treatments, or steroids given for an allergic or transfusion reaction

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 21 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: +8618980601240

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
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Registry
ClinicalTrials.gov
Start date
31 August 2021
Est. completion
31 October 2024

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Number of participants with dose limiting toxicities (DLTs)

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: 21 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