Leukaemia Trial, Recruiting NCT06329999 Sponsor: Ruijin Hospital Condition: Leukaemia
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Leukaemia Trial, Recruiting

NCT06329999
Recruiting Not Applicable

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 fully understand the study, choose to take part voluntarily, and sign a consent form
  • People aged between 18 and 75 years old (including those who are exactly 18 or 75)
  • People who have been clinically confirmed to have AML (acute myeloid leukaemia) or MDS-IB2 (a type of bone marrow disorder, classified using WHO 2022 standards), where the AML meets at least one of these conditions: it was caused by previous cancer treatment; the person previously had a condition called MDS; the AML is linked to certain gene or chromosome changes associated with MDS; the person previously had a condition called CMML; the person is aged 60 or older; or the person previously had certain blood disorders (ET, PV, or MF) with bone marrow scarring rated at grade 2 or lower
  • People assessed as being in reasonably good overall health, with an activity/function score below 3 (ECOG scale), no major other illnesses, and meeting certain thinking and physical ability assessments (confirm with trial site for exact standards)
  • People with an expected survival of at least 3 months
  • People whose liver and kidney function blood test results are within acceptable ranges as determined by the trial team
  • People who have completed any previous MDS treatments (other than blood transfusions) at least 2 weeks before starting the study treatment, with any side effects from those treatments having settled to an acceptable level beforehand (a medication called hydroxyurea may be allowed up to 24 hours before starting, in cases of rapidly progressing disease)

Who may not be able to join:

  • People who have previously been treated with a drug called mitoxantrone or mitoxantrone liposomes
  • People who have previously received a type of chemotherapy drug called doxorubicin or other similar drugs (anthracyclines), where the total lifetime dose has exceeded a certain level
  • People who have received any anti-cancer treatment — including surgery, chemotherapy, targeted therapy, or another clinical trial drug — within 4 weeks before the first dose of the study drug (or within 5 half-lives of that drug)
  • People with certain heart rhythm or electrical problems, including a condition called long QTc syndrome or a QTc interval greater than 480 milliseconds on a heart tracing
  • People with a complete left bundle branch block, or a second- or third-degree heart conduction block
  • People with serious, uncontrolled heart rhythm problems that require ongoing medication
  • People with a heart failure classification of grade II or higher (as rated by a standard cardiology scale — confirm with trial site)
  • People whose heart pumping strength (LVEF) is below 50%
  • People who, in the 6 months before joining the trial, have had a heart attack, unstable chest pain, serious irregular heartbeat, significant disease around the heart, or signs of reduced blood flow to the heart on a heart tracing
  • People who currently have, or have previously had, another cancer — with some exceptions, such as certain well-controlled skin cancers, early-stage breast or cervical cancers, or other cancers that have been well controlled for more than 6 months without chemotherapy
  • People with uncontrolled conditions affecting the whole body, such as active infection, uncontrolled high blood pressure, or uncontrolled diabetes
  • People whose leukaemia has spread to the central nervous system (brain and spinal cord)
  • People with secondary AML where bone marrow scarring is rated at grade 3 or higher
  • People with a type of leukaemia called CML that has progressed to a sudden-change (blast) phase
  • People whose AML is associated with certain chromosome changes that are linked to a better outlook (specific types listed in the original criteria — confirm with trial site), or people with a type called acute promyelocytic leukaemia
  • People who are HIV-positive
  • People with active hepatitis B or hepatitis C infection, based on specific blood test results as assessed by the trial team
  • People with a known history of allergic reactions to the study drug or its ingredients
  • People with a history of serious neurological or mental health conditions
  • People whom the trial researchers consider unsuitable for other reasons

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 6 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: sujiang Zhang, Doctor, Hematological Depaement, Ruijin Hospital

Phone: 13816205940

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
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
3 February 2024
Est. completion
31 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

CRc

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: 6 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