Phase 1 Leukaemia Trial, Recruiting NCT04275518 Sponsor: Ascentage Pharma Group Inc. Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT04275518
Recruiting Phase 1

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 diagnosed with acute myeloid leukemia (AML) that has come back or stopped responding to treatment, or you have a high-risk form of a bone marrow condition called MDS, confirmed by a tissue test.
  • You are 18 years of age or older.
  • Your heart, liver, kidneys, and other organs are working well enough to participate (confirm with trial site).
  • Doctors expect you to live for at least 12 weeks.
  • You are generally well enough to carry out daily activities with little or no limitation (rated 0 or 1 on a standard fitness scale used by doctors).
  • You are able to understand what the study involves and are willing to sign a consent form (a legal representative may sign on your behalf if needed).
  • Your white blood cell count is below a certain level — medication may be used beforehand to help meet this requirement (confirm with trial site).

Who may not be able to join:

  • You have a specific type of leukemia called acute promyelocytic leukemia (APL).
  • You have received certain cancer treatments recently — the required waiting period since your last treatment must have passed before joining (confirm exact timeframes with trial site).
  • You have serious uncontrolled health problems, such as an active uncontrolled infection, severe heart failure, unstable chest pain, significant heart rhythm problems, or a mental health condition that would make it hard to follow the study rules.
  • You have an active infection requiring antibiotic or antifungal treatment, or you have active hepatitis B, hepatitis C, or HIV.
  • You have had a stem cell transplant using someone else's cells at any time, or your own cells within the past 12 months.
  • Your leukemia has spread to your brain or spinal fluid and is not under control.
  • You have previously been treated with a specific type of drug that targets a protein pathway called MDM2-p53.
  • The study doctor feels, for any reason, that joining the trial would not be safe or suitable for you.
  • You have had another type of cancer in the past 2 years — though some exceptions may apply, such as certain skin cancers or early-stage cancers that were fully treated (confirm with trial site).

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 22 July 2026
Phase 1: approximately ~10% 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., Blood Diseases Hospital Chinese Academy of Medical Sciences

Phone: +86-18622662361

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 1
Sponsor
Ascentage Pharma Group Inc.
Registry
ClinicalTrials.gov
Start date
6 July 2020
Est. completion
31 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Dose Limiting Toxicities (DLT)

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: 22 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