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New chemo cocktail aims to boost stem cell transplant success in leukemia

NCT ID NCT07644481

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial is testing a combination of three chemotherapy drugs—clofarabine, busulfan, and melphalan—given before a stem cell transplant in 30 adults with acute myeloid leukemia (AML) who are in first remission. The goal is to see if this conditioning regimen improves survival and reduces the chance of the cancer coming back. Researchers will track outcomes like overall survival and relapse rates over two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Clofarabine, busulfan, and melphalan (chemotherapy drugs)
What this could lead to
If successful, this could offer a more effective conditioning regimen for stem cell transplants in AML, potentially improving long-term survival and reducing relapse.
What could go wrong
This is a small, early-phase study with only 30 participants and no comparison group, so results may not apply broadly. The chemotherapy combination also carries risks like infection and organ damage.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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

18 to 60 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: * 1.Aged from 18 to 60 years inclusive, with no restriction on gender; * 2.Patients diagnosed with acute myeloid leukemia (AML, excluding acute promyelocytic leukemia, APL) by bone marrow morphological, immunological and genetic examinations according to the 2022 World Health Organization (WHO) classification, who have achieved first complete remission (CR1) after induction therapy; * 3.Meeting any of the following criteria upon clinical evaluation: 1. AML classified as intermediate or adverse genetic risk according to the 2022 ELN genetic risk stratification; 2. AML with positive measurable residual disease (MRD) before transplantation; * 4.Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0-2; * 5.Estimated survival time more than 6 months; * 6.Meeting the indications for allogeneic hematopoietic stem cell transplantation (allo-HSCT), and having an eligible hematopoietic stem cell donor with qualified physical examination, including HLA-matched sibling donor, unrelated donor (high-resolution HLA 9-10/10 matched) or haploidentical related donor; * 7.Adequate major organ function meeting the following criteria: 1. Total bilirubin (TBIL) ≤ 2 times the upper limit of normal (ULN); Alanine transaminase (ALT) and Aspartate transaminase (AST) ≤ 3 × ULN; 2. Serum creatinine (Cr) ≤ 1.5 × ULN, or estimated creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault glomerular filtration formula; 3. Coagulation function meeting the following standards: Prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (without anticoagulant therapy); 4. Electrocardiogram showing no acute myocardial infarction or severe arrhythmia; Echocardiography with left ventricular ejection fraction (LVEF) ≥ 50%, without significant cardiomegaly, valvular heart disease or congenital heart disease; 5. Pulmonary function tests: FEV1, FVC and DLCO ≥ 60% of predicted value; * 8.Willing to provide available diagnostic evidence or undergo bone marrow aspiration and biopsy prior to study treatment, and agree to receive regular bone marrow aspiration and biopsy after study treatment; * 9.Must sign the informed consent form prior to study enrollment, signed by the patient personally or immediate family members. If signature by the patient is deemed detrimental to disease treatment based on clinical condition assessment, the informed consent shall be signed by the legal guardian or immediate family member of the patient. Exclusion Criteria: * 1.Refractory/relapsed AML; * 2.Known hypersensitivity to any drugs in the conditioning regimen or their excipients; * 3.Major surgery within the past 4 weeks (excluding diagnostic surgical procedures); * 4.History of or concurrent other malignant tumors (excluding well-controlled non-melanoma basal cell carcinoma of the skin, breast/cervical carcinoma in situ, and other malignancies well controlled without treatment for more than five years); * 5\. Uncontrolled systemic diseases (such as uncontrolled hypertension, diabetes mellitus, etc.); * 6.Active hepatitis B or hepatitis C infection:(Hepatitis B virus surface antigen positive, hepatitis B core antibody positive with HBV-DNA level exceeding 1×103 copies/mL;Hepatitis C virus RNA level exceeding 1×10 3 copies/mL); * 7.Uncontrolled ongoing infection, or patients requiring mechanical ventilation or with hemodynamic instability; * 8.Patients with psychiatric disorders or other medical conditions who are unable to comply with study treatment and monitoring requirements; * 9.Participation in another ongoing clinical trial, or enrollment in any other drug clinical trial within the past 1 month; * 10.Pregnant or lactating females, and patients who refuse to use effective contraception during the study period; * 11.Patients who are unable to understand the trial protocol, adhere to medication instructions, or refuse to sign the informed consent form; * 12.Patients deemed ineligible for enrollment by the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The official record

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

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  2. A doctor treating you

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