Experimental combo aims to control MDS without transplant
NCT ID NCT07238686
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a combination of venetoclax (a targeted drug), standard chemotherapy (azacitidine or decitabine), and an infusion of immune cells from a partially matched donor for people with intermediate- or high-risk myelodysplastic syndromes (MDS) who cannot or choose not to have a bone marrow transplant. The study will enroll 40 participants and measure overall survival and response rates. The goal is to see if this approach can control the disease safely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Venetoclax, azacitidine or decitabine, and donor immune cells
- What this could lead to
- If it works, this could offer a new treatment option for people with higher-risk MDS who cannot have a standard bone marrow transplant.
- What could go wrong
- This is a small, early-phase trial (40 people) testing a complex combination. It may not work better than existing treatments, and there are risks of infection, bleeding, or graft-versus-host disease from the donor cells.
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 40 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. * Confirmed diagnosis of MDS according to the World Health Organization (WHO) 5th edition classification, based on histopathology and cytogenetics. * Risk stratification according to the Revised International Prognostic Scoring System (IPSS-R) must place the patient in the intermediate-, high-, or very high-risk category. * Not candidates for or refuse allogeneic hematopoietic stem cell transplantation. * 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: * 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. * Major surgery within 4 weeks prior to enrollment. * Life-threatening illness other than MDS 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 adding venetoclax make donor stem cell transplants safer for High-Risk blood cancers?
- Can starting anemia drug sooner keep MDS patients off transfusions?
- Blood cancer registry tracks thousands to map disease course
- New drug combination targets Hard-to-Treat blood cancers
- Can a calming drug make cord blood transplants safer?
- Can a Three-Drug combo shield stem cell transplant patients from a dangerous immune attack?