New hope for elderly blood cancer patients: experimental transplant prep shows promise
NCT ID NCT07500753
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new combination of drugs (cladribine, lisaftoclax, busulfan, and others) given before a stem cell transplant in 30 older adults (age 50+) with relapsed or refractory acute myeloid leukemia or myelodysplastic syndromes. The goal is to see if this approach can reduce side effects, lower relapse rates, and improve survival compared to standard treatments. Participants will be followed for at least two years to track outcomes like relapse-free survival and engraftment success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cladribine, lisaftoclax, busulfan, and other chemotherapy drugs
- What this could lead to
- If successful, this could offer a more tolerable and effective transplant preparation for older adults with relapsed or refractory AML/MDS, potentially improving long-term survival.
- What could go wrong
- This is a small, early-phase study with only 30 participants, so results may not apply broadly. The drug combo carries risks like infection, organ damage, and graft-versus-host disease.
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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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 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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50 years and older
- 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: * Age ≥ 50years. * Meet the 2022 World Health Organization (WHO) diagnostic criteria for acute myeloid leukemia (AML),MDS, and be diagnosed with relapsed/refractory AML after treatment, fulfilling any of the following definitions: * Relapsed AML: Reappearance of leukemic cells in peripheral blood, bone marrow blasts \>5% (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary infiltration of leukemic cells after achieving complete remission (CR or CRi). * Refractory AML: Newly diagnosed cases that failed to respond after 2 courses of standard therapy; patients who relapsed within 12 months after consolidation therapy following CR; patients who relapsed after 12 months but failed to respond to conventional chemotherapy; patients with 2 or more relapses; persistent extramedullary leukemia. * MDS:Myelodysplastic Neoplasms (MDS)MDS are a group of clonal hematopoietic stem cell disorders characterized by: Dysplastic hematopoiesis (abnormal development of blood cells in the bone marrow); Cytopenias (one or more lineages of blood cells are reduced in number); Increased risk of transformation to acute myeloid leukemia (AML).Key diagnostic criteria (per WHO 2022 classification): Persistent cytopenia(s) for ≥4 months (unless specific genetic abnormalities are present); Morphological dysplasia in ≥10% of cells in one or more lineages; Presence of MDS-defining genetic abnormalities (e.g., SF3B1 mutation, isolated del(5q), TP53 biallelic alteration). * Cardiac, hepatic, and renal function test results within the following limits: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN);Total bilirubin ≤ 3 × ULN;Serum creatinine ≤ 2 × ULN or creatinine clearance ≥ 40 mL/min;Left ventricular ejection fraction (LVEF) measured by echocardiography or multigated acquisition (MUGA) scan within the normal range (\>50%). * Have a suitable allogeneic donor. * Expected survival ≥ 1 month. * Karnofsky Performance Status (KPS) ≥ 60%, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; * The patient understands the study protocol and voluntarily signs the informed consent form. Exclusion Criteria: * Patients had serious adverse reactions to investigational drugs such as allergies; * Patients with a history of immunodeficiency, or other acquired or congenital diseases, immunodeficiency diseases, and a history of organ transplantation; * Patients with hypertension, ventricular arrhythmia requiring clinical intervention, acute coronary syndrome, congestive heart failure, stroke, or other grade III or higher cardiovascular events within 6 months; * Patients received Class II or higher surgery within 4 weeks prior to enrollment; * Patient has an active and difficult-to-control infection, including but not limited to active fungal, bacterial, or viral infections that require systemic treatment, such as active HIV, hepatitis B or C; * Patient has active central nervous system leukemia infiltration; * Pregnant or lactating patients; * Patient is currently participating in another clinical studies; * Other conditions where the investigator deems the patient unsuitable for inclusion.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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The First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, 215006, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a drug duo keep High-Risk blood cancers at bay after transplant?
- Can a new pill boost the power of an existing leukemia treatment?
- Personalized dosing may improve stem cell transplant survival in blood cancer patients
- Could bone marrow from deceased donors cure blood cancers?
- Single-Dose gene therapy aims to reprogram immune cells against tough leukemia
- New pill targets rare gene mutation in Hard-to-Treat blood cancers