Phase 1 Leukaemia Trial, Recruiting NCT05445011 Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT05445011
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:

  • People aged 18 to 70 years old (any gender)
  • People diagnosed with FLT3-positive acute myeloid leukemia (a specific type of blood cancer with a particular genetic marker)
  • People whose doctors expect them to live for more than 3 months
  • People with a physical functioning score of 0–2 on a standard medical scale (meaning able to carry out normal activity with at most moderate limitations)
  • People whose leukemia has not responded to standard treatment, or has come back after treatment — specifically those who meet at least one of these situations:
    • After achieving remission, leukemia cells reappeared in the bone marrow, blood, or other areas of the body
    • People who had no response after 2 rounds of initial treatment
    • People whose leukemia came back within 12 months of achieving remission after intensive treatment
    • People whose leukemia came back after 12 months but did not respond to standard chemotherapy
    • People who have relapsed two or more times, or have leukemia present outside the bone marrow
  • People whose kidney, heart, lung, liver, and blood clotting functions meet the specific levels required by the trial (the trial site will assess these through tests)
  • People who have read and signed a consent form showing they understand the trial

Who may not be able to join:

  • People who have had another type of cancer in the past 5 years (with some exceptions, such as certain fully treated skin cancers, cervical cancer in situ, localised prostate cancer, or breast ductal carcinoma in situ — confirm with trial site)
  • People who have active hepatitis B, hepatitis C, HIV, cytomegalovirus (CMV), or syphilis infections, based on blood test results
  • People with serious heart conditions, including unstable chest pain, a heart attack within the past 6 months, significant heart failure, or serious irregular heartbeat
  • People with severe ongoing liver, kidney, or metabolic diseases that require medication
  • People who have an active or uncontrolled infection requiring treatment within 7 days before joining the trial (minor urinary or upper respiratory infections may be exceptions — confirm with trial site)
  • Women who are pregnant or breastfeeding, women planning a pregnancy within 2 years after treatment, or men whose partners are planning a pregnancy within 2 years after treatment
  • People who have been taking steroid tablets or injections regularly within the 7 days before joining, or who are expected to need long-term steroids during the trial (steroid inhalers or creams are generally not included — confirm with trial site)
  • People who have participated in another clinical trial within the past month
  • People who show signs that the leukemia has spread to the brain or spinal fluid
  • People who have graft-versus-host disease (a complication after some transplants) or who need medications that suppress the immune system
  • People with a history of epilepsy or other conditions affecting the brain or nervous system
  • People with a primary immune deficiency condition (a condition where the immune system does not work properly from birth)
  • People whose doctors determine that collecting and preparing their cells for treatment is not suitable
  • People considered unsuitable for other reasons, at the discretion of the medical team

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 27 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: Heng Mei, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Phone: 027-8572600

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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Registry
ClinicalTrials.gov
Start date
14 June 2022
Est. completion
14 June 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Maximal tolerable dose (MTD)

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: 27 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