Phase 2 Leukaemia Trial, Recruiting NCT05584761 Sponsor: The First Affiliated Hospital with Nanjing Medical University Condition: Leukaemia
Back to Leukaemia

Phase 2 Leukaemia Trial, Recruiting

NCT05584761
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 diagnosed with Myelodysplastic Syndrome (MDS) — a bone marrow disorder — classified as intermediate, high, or very high risk based on a standard scoring system used by doctors
  • People diagnosed with a condition called CMML-2 (a type of blood cancer) with a white blood cell count below a certain level, confirmed by bone marrow testing
  • People diagnosed with a type of acute myeloid leukemia (AML) that developed from a prior bone marrow or blood disorder
  • People who, based on local medical standards, are not suitable candidates for a stem cell transplant from a donor
  • People for whom a doctor has determined that treatment with a medicine called azacytidine is appropriate, based on local medical guidelines
  • People aged between 18 and 80 years old
  • People whose liver enzyme levels (ALT, AST), bilirubin, creatinine, and heart enzyme levels are within acceptable ranges as determined by blood tests
  • People whose heart pumping function (measured by an ultrasound of the heart) is at or above 50%
  • People whose kidneys are filtering at or above a minimum level as measured by a standard calculation
  • People who are well enough to carry out daily activities, rated 0–2 on a standard medical scale that doctors use to assess general wellbeing
  • People (or their legal representative) who are willing and able to sign a consent form agreeing to take part in the study

Who may not be able to join:

  • People diagnosed with certain other blood or bone marrow conditions, including a type of leukemia that is BCR/ABL positive, primary myelofibrosis, polycythemia vera, or essential thrombocythemia
  • People with MDS that is classified as low risk on standard scoring systems
  • People diagnosed with acute promyelocytic leukemia, myeloid sarcoma, or an advanced phase of BCR/ABL positive chronic myelogenous leukemia
  • People who are allergic to any of the medicines used in this study
  • People who are pregnant, breastfeeding, or of reproductive age and unwilling to use contraception during the study
  • People whose liver or kidney function does not meet the levels required for inclusion
  • People with a heart condition causing symptoms or reduced heart function, rated Class 2 or higher on a standard heart health scale
  • People currently living with another cancer, unless the other cancer was successfully treated more than 5 years ago with no signs of return, or was a specific type of well-controlled skin cancer or early-stage cervical condition (confirm with trial site for exact details)
  • People with a known history of HIV or syphilis, or who have an active Hepatitis B or Hepatitis C infection
  • People with serious active heart problems such as uncontrolled irregular heartbeat, heart failure, a heart attack within the past 6 months, or heart disease rated Class 3 or 4 on a standard heart health scale
  • People with another medical condition or active infection that may interfere with the study or pose a risk to their participation
  • People who are unable to understand or follow the study procedures
  • People under 12 years old or over 80 years old
  • People who have had major surgery within 4 weeks before joining the trial
  • People who are currently taking part in, or have taken part in, another clinical trial within the month before enrolling
  • People for whom a matching cord blood stem cell donor cannot be found
  • People with a current illegal drug addiction
  • People with a mental health condition or cognitive disorder that would affect their ability to participate

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 19 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: +8615950523133

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
Registry
ClinicalTrials.gov
Start date
1 March 2022
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

overall survival rate; complete response rate; Hematopoietic function recovery time

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: 19 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