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New drug combo aims to boost stem cell transplant success in older blood cancer patients

NCT ID NCT07396480

Disease control Sponsor: First Affiliated Hospital of Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether adding the targeted drug venetoclax to standard chemotherapy (fludarabine and melphalan) before a donor stem cell transplant can improve outcomes for patients over 50 with acute myeloid leukemia or myelodysplastic syndrome. The study will compare the new three-drug regimen against the standard two-drug regimen in 186 participants. The goal is to reduce relapse and improve survival without increasing severe graft-versus-host disease.

What this could mean

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

Active substance
Venetoclax (a targeted pill) added to fludarabine and melphalan chemotherapy
What this could lead to
If successful, this could become a new standard conditioning regimen before stem cell transplant for older AML/MDS patients, improving long-term survival and reducing relapse.
What could go wrong
This is an early-phase 3 trial with 186 participants, so results are not yet proven. Adding venetoclax may increase side effects like infections or organ toxicity, and the benefit over standard chemo is uncertain.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 186 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

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

50 to 75 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 \> 50 years; 2. Confirmed as acute myeloid leukemia (AML) in remission prior to transplantation, myelodysplastic syndrome (MDS; IPSS: Intermediate-2, high; or IPSS-R: Intermediate, high, very high; or IPSS-M: moderate-high, high, and very high), or myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) by morphology, immunology, cytogenetics and molecular biology (MICM) typing; 3. Having an eligible donor and scheduled to undergo allogeneic hematopoietic stem cell transplantation (Allo-HCT) from a related or unrelated donor; 4. Karnofsky Performance Score ≥ 70; 5. Eastern Cooperative Oncology Group (ECOG) Performance Status \< 3; 6. Expected survival time \> 12 weeks; 7. Voluntarily signing the informed consent form and being able to understand and comply with all study requirements. Exclusion Criteria: 1. Complicated with severe cardiac insufficiency with a left ventricular ejection fraction (EF) \< 60%; or complicated with severe arrhythmia, and assessed by the investigator as unable to tolerate the intensive conditioning regimen; 2. Complicated with severe pulmonary insufficiency (obstructive and/or restrictive ventilatory disorder), and assessed by the investigator as unable to tolerate the intensive conditioning regimen; 3. Complicated with severe liver function impairment, with liver function indicators (alanine aminotransferase \[ALT\], total bilirubin \[TBIL\]) exceeding 3 times the upper limit of normal (ULN); and assessed by the investigator as unable to tolerate the intensive conditioning regimen; 4. Complicated with severe renal insufficiency, with serum creatinine (Cr) exceeding 2 times the upper limit of normal (ULN); or with a 24-hour creatinine clearance rate (Ccr) \< 50 ml/min, and assessed by the investigator as unable to tolerate the intensive conditioning regimen; 5. Suffering from severe active infection prior to transplantation, and assessed by the investigator as unable to tolerate the intensive conditioning regimen; 6. Having a history of allergic reactions or severe adverse reactions to the drugs involved in the conditioning regimen, and assessed by the investigator as ineligible for enrollment; 7. Other reasons for ineligibility assessed by the investigator.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome myelodysplastic/myeloproliferative neoplasm myeloid neoplasm

As listed by the trial registrant

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

Acute myeloid leucemia Allogeneic hematopoietic stem cell transplantation Conditioning Myeldysplastic syndrome (MDS) Myeloid malignancies Venentoclax

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. 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

  • Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)

    RECRUITING

    Nanjing, Jiangsu, China

  • Nanfang Hospital Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, China

  • Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)

    RECRUITING

    Chongqing, China

  • Shanghai General Hospital (Shanghai First People's Hospital)

    RECRUITING

    Shanghai, China

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, China

  • The Affiliated People's Hospital of Ningbo University

    RECRUITING

    Ningbo, China

  • The First Affiliated Hospital of Fujian Medical University

    RECRUITING

    Fuzhou, Fujian, China

  • The First Affiliated Hospital of Ningbo University

    RECRUITING

    Ningbo, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, China

  • The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)

    RECRUITING

    Hangzhou, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, China

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, China

  • Xiangya Hospital Central South University

    RECRUITING

    Changsha, Hunan, China

  • Zhejiang Cancer Hospital & Hangzhou Institute of Medicine, Chinese Academy of Sciences

    RECRUITING

    Hangzhou, Zhejiang, China

  • Zhejiang Provincial Peoples's Hospital

    RECRUITING

    Hangzhou, China

  • the First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 311121, China

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