Can mismatched donor cells boost leukemia survival?
NCT ID NCT07078591
First seen Oct 13, 2026 · Last updated Oct 14, 2026 · Updated 1 time
Summary
Researchers test whether adding an infusion of HLA-mismatched donor cells to venetoclax-based chemotherapy improves survival in adults with newly diagnosed acute myeloid leukemia. The trial enrolls 50 participants who have not received prior anti-leukemia treatment. The approach combines standard drugs with a donor cell infusion to see if it can control the disease better than chemotherapy alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- venetoclax combined with HLA-mismatched donor G-CSF mobilized peripheral blood mononuclear cell infusion
- What this could lead to
- If it works, this approach could offer a new way to treat newly diagnosed AML, possibly improving survival without a fully matched donor.
- What could go wrong
- This is a Phase 2 trial with 50 participants, so results may not hold in larger studies. Donor cell infusions carry risks of immune reactions and infections.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jun 2031
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 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 \>=18 years, male or female, non-limited by race or ethnicity. * No prior anti-acute leukemia treatment (including hypomethylators for leukemia or MDS) with the exception that prior hydroxyurea and/or leukapheresis are permitted. * Confirmed acute myeloid leukemia in accordance with WHO criteria with a WBC count \< 25 × 109/L. * Adequate hepatic function including alanine transaminase (ALT) and aspartate aminotransferase (AST )\<= 3 × upper limit of normal(ULN), and total bilirubin \<= 1.5 × ULN. * Adequate renal function including serum creatinine \<= 2 × ULN or CrCl\>= 40mL/min. * LVEF measured by echocardiogram is within the normal range (LVEF \> 50%). * The subject must have one donor who is \>= 18 years old and HLA matched at 0-7/10 loci (i.e., at least 3 HLA loci must be mismatched). In addition, the donor voluntarily donates hematopoietic stem cells and signs the consent form. * Each subject (or his/her legal representatives) must sign the Informed Consent Form (ICF), indicating that he/she understands the purpose and procedures of research, and is willing to participate in research. * Donor inclusion criteria: The donor meets the institution's criteria for related peripheral blood hematopoietic stem cell donors. The donor must be able to tolerate the cell separation and collection process, and sign the Informed Consent Form. Exclusion Criteria: * Acute promyelocytic leukemia, myeloid sarcoma, chronic myeloid leukemia accelerated phase and blast crisis. * Uncontrolled infection or hemorrhage. * Cardiovascular disease with clinical significance, such as uncontrolled or highly symptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or New York Heart Association (NYHA) function class 3 (moderate) or class 4 (severe) heart disease. * Uncontrolled autoimmune disease or requiring immunosuppression treatment. * History of severe blood infusion reaction. * Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception. * Psychiatric disorder or cognitive impairment that in the researcher's judgment would make the subject not likely to adhere to the protocol requirements. * Any major surgery within 4 weeks before enrollment. * Life-threatening illness other than AML or uncontrolled intercurrent illness.
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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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Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital
RECRUITINGBeijing, 100071, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an oral tablet offer a new option for hard-to-treat blood cancers?
- Can an Immune-Engaging drug team up with chemotherapy against AML?
- New pill tested against Hard-to-Treat cancers
- Single-Cell maps of leukemia may reveal why some tumors resist venetoclax
- Can stretchy bands help stem cell patients bounce back faster?
- Can a gentler transplant cure leukemia in older adults?