New chemo cocktail aims to boost stem cell transplant success in leukemia
NCT ID NCT07644481
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
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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
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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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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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.
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Other studies related to the condition(s) this trial covers.
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