Phase 3 Leukaemia Trial, Recruiting NCT06389292 Sponsor: Ascentage Pharma Group Inc. Condition: Leukaemia
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Phase 3 Leukaemia Trial, Recruiting

NCT06389292
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:

  • You have been newly diagnosed with acute myeloid leukemia (AML) and are not suitable for standard chemotherapy.
  • Your doctors expect you to live for at least 3 months.
  • You are able to swallow and take medicine by mouth.
  • You are aged 70 or older with a general health/activity level rated as good to moderate (ECOG 0–2), OR you are aged 18 to 69 with a general health/activity level rated as good to somewhat limited (ECOG 0–3) (confirm with trial site if unsure about your score).
  • Your kidneys are working well enough as shown by recent blood tests.
  • Your white blood cell count is at or below a certain level (30×10⁹/L) as measured by a blood test.
  • Your liver is working well enough as shown by recent blood tests.
  • You and your partner are willing to use effective birth control during the trial (if applicable).
  • You are able to understand the study information and are willing to sign a consent form.
  • You are willing and able to attend all required study visits and follow-up appointments.

Who may not be able to join:

  • You have been diagnosed with a specific type of leukemia called acute promyelocytic leukemia, or your AML has a specific genetic marker called BCR-ABL1 positive.
  • The leukemia has spread to your brain or spinal cord (central nervous system).
  • You have an active infection that is not under control and requires treatment.
  • You have taken certain medications that strongly affect how the body processes drugs (CYP3A4 inducers or inhibitors) within a specific period before starting the trial (confirm with trial site which medications are affected).
  • You have previously received treatment for any blood disorder.
  • You have significant heart problems rated as Class 3 or higher by your doctor using a standard heart health scale.
  • You have a condition that prevents you from absorbing medicines taken by mouth, or that affects how your body absorbs drugs.
  • You have a history of any other type of cancer before joining this study.
  • The trial doctors feel, for any other reason, that the trial may not be right for you.

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 12 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: Jianxiang Wang, M.D., Hematology Hospital of the Chinese Academy of Medical Sciences

Phone: +86-20-28068501

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
Ascentage Pharma Group Inc.
Registry
ClinicalTrials.gov
Start date
11 June 2024
Est. completion
25 May 2028

Where this trial is recruiting

🇨🇳 China 🇷🇺 Russia

Primary endpoints

Overall Survival(OS)

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: 12 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