New chemo combo aims to cut leukemia relapse after transplant

NCT ID NCT06816134

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a new chemotherapy combination (TmBU) works better than the standard one (mBUCY) before a stem cell transplant in people with high-risk or hard-to-treat acute leukemia. About 48 patients aged 65 or younger will be randomly assigned to one of the two regimens. The main goal is to see if the new combo lowers the chance of leukemia coming back within two years after transplant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Confirmed diagnosis of AML or ALL according to WHO 2022 guideline criteria, with indications for allo-HSCT list below: 1. Relapsed/primary refractory (definitions refer to NCCN 2025) or genetic high-risk group AML at diagnosis (risk stratification refers to ELN 2022) 2. High-risk at diagnosis (risk stratification refers to ELN 2022) or MRD positive before transplantation B-ALL 3. Confirmed diagnosis of T-ALL 4. History of central nervous system leukemia (CNSL) or histopathologically confirmed extramedullary manifestation (EMD) during the course of the AML or ALL * Age 15-65 years old (≤ 65 years old) * HCT-CI score \< 2 points ECOG 0-2 points * Adequate organ function: 1. Cardiac NYHA grade ≤ 2, left ventricular ejection fraction ≥55% 2. Creatinine clearance ≥ 50ml/min 3. ALT and AST ≤ 2.5 times the upper limit of the normal range, and total bilirubin ≤ 1.5 times the upper limit of the normal range 4. Oxygen saturation \> 92% without oxygen * Expected survival time ≥ 3 months * Ability to understand and voluntarily sign the informed consent form Exclusion Criteria: * With other malignant tumors and have received any treatment for this tumor within the past 3 years * Previous or current other CNS disease (such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis) or any CNS-related autoimmune disease * HIV/Syphilis infection or uncontrolled active other infections (bacteria or fungus or virus is included) * With active hepatitis B or hepatitis C infection * Patients received cardiac angioplasty or stent implantation within 12 months before signing the informed consent form, or have symptoms requiring medical treatment for coronary heart disease * With primary immunodeficiency or active autoimmune disease * Previous history of severe immediate hypersensitivity reactions to any of the drugs to be used in this study * Received a live vaccine within 6 weeks prior to screening * Pregnant, lactating females and patients of childbearing potential who are unwilling to use contraception * Inability to cooperate with the requirements of study, treatment and monitoring due to psychiatric illness or other conditions * Patients not suitable for the study according to the investigator's assessment

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute lymphoblastic leukemia are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia acute myeloid leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.