Phase 2 Leukaemia Trial, Recruiting NCT06221683 Sponsor: Children's Hospital of Soochow University Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT06221683
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 AML (acute myeloid leukemia) and have not yet received treatment for it
  • Children and young people under 18 years old
  • People who previously received hydroxyurea or a limited amount of a drug called cytarabine before their diagnosis, as long as the cytarabine was given for no more than 5 days at a low total dose
  • People whose liver is working well enough, whose kidneys are filtering at an adequate level, and whose heart and oxygen levels are within acceptable ranges (confirm specific values with trial site)
  • People who do not have an active infection, or whose infection symptoms have fully resolved for more than 3 days
  • People who are generally able to carry out daily activities with little or no difficulty (measured using a standard scale called ECOG, score must be less than 2)
  • People whose expected survival is greater than 12 weeks
  • People (and/or their parent or legal guardian) who are willing to give written consent to participate

Who may not be able to join:

  • People diagnosed with a specific type called acute megakaryocytic leukemia (AMKL)
  • People diagnosed with a specific type called acute promyelocytic leukemia (APL)
  • People whose AML developed as a result of previous cancer treatment, or who have AML that clearly developed from a blood condition called MDS
  • People with a related blood or bone marrow disorder such as juvenile myelomonocytic leukemia (JMML)
  • People whose AML developed from an inherited bone marrow failure condition, such as Fanconi anemia
  • People whose AML is linked to Down syndrome
  • People who are only able to receive temporary or one-off cancer treatments and cannot follow the full treatment plan required by the trial
  • People who have another serious illness or mental health condition that could affect their safety, their ability to take part fully, or the reliability of the trial results (confirm with trial site, as individual cases are reviewed by the trial leadership)
  • People who are severely malnourished, have a serious infection, have significant heart failure, or whose body is otherwise unable to tolerate chemotherapy
  • People whose AML has come back after a previous remission (relapsed AML)
  • People whose treating doctor decides, based on physical condition, personal circumstances, or other factors, that participation would not be appropriate

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

Principal Investigator: Shaoyan Hu, MD, PhD, Children 's Hospital of Soochow University

Phone: +86-13771870462

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
Children's Hospital of Soochow University
Registry
ClinicalTrials.gov
Start date
1 January 2024
Est. completion
1 December 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Rate of CR/CRi with negative MRD; Event-free survival; Cumulative incidence of relapse

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