Actively Recruiting
Fludarabine Plus Melphalan Versus Addition of Venetoclax to Fludarabine/Melphalan Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in AML/MDS Patients Aged Over 50 Years Multicenter Randomized Phase 3 Trial
Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-03-17
186
Participants Needed
18
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying conditioning regimens for elderly patients over 50 years old with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who are undergoing allogeneic hematopoietic cell transplantation (Allo-HCT). The study evaluates whether adding Venetoclax, a targeted drug, to the standard fludarabine plus melphalan (Flu+Mel) regimen improves long-term outcomes. This trial is a multicenter, randomized phase 3 study addressing the challenge that elderly patients have higher relapse rates and need safer, more effective transplant conditioning. Participants are randomly assigned to one of two groups. The control group receives the standard conditioning regimen of fludarabine plus melphalan, with melphalan doses adjusted by age. The experimental group receives Venetoclax along with fludarabine and melphalan, with Venetoclax doses adjusted if certain antifungal medications are used and melphalan dose adjusted by age. Venetoclax is given daily from days -8 to -2, fludarabine from days -7 to -3, and melphalan on day -2 before transplant. During the study, participants will be monitored for graft-versus-host disease (GVHD) and relapse-free survival over two years as the main outcome. Other outcomes include overall survival, progression-free survival, non-relapse mortality, and immune recovery. Researchers will assess safety and effectiveness through regular follow-ups. The trial aims to determine if adding Venetoclax can improve survival and reduce complications after transplant in this patient group.
CONDITIONS
Brief Title
Fludarabine Plus Melphalan Versus Addition of Venetoclax to Fludarabine/Melphalan Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in AML/MDS Patients Aged > 50 Years: a Multicenter, Randomized, Phase 3 Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged over 50 years
- Diagnosed with acute myeloid leukemia (AML) in remission, myelodysplastic syndrome (MDS) with specified risk levels, or MDS/myeloproliferative neoplasm (MDS/MPN) confirmed by detailed testing
- Have an eligible related or unrelated donor for allogeneic hematopoietic stem cell transplantation
- Karnofsky Performance Score 70 or higher
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than 3
- Expected survival time longer than 12 weeks
- Able and willing to provide informed consent and follow study requirements
You will not qualify if you...
- Severe heart problems including left ventricular ejection fraction below 60% or severe arrhythmia making intensive conditioning unsafe
- Severe lung problems causing obstructive or restrictive ventilatory disorder preventing intensive conditioning
- Severe liver impairment with liver tests more than three times the upper normal limit
- Severe kidney impairment with serum creatinine above twice normal or creatinine clearance under 50 ml/min
- Severe active infection before transplantation making conditioning unsafe
- History of severe allergic or adverse reactions to conditioning drugs
- Other conditions deemed by the investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 days
Participants receive a conditioning regimen prior to allogeneic hematopoietic stem cell transplantation. This includes fludarabine and melphalan for the control group, and venetoclax combined with fludarabine and melphalan for the experimental group. The regimens occur over several days with drug doses adjusted according to age and co-administered medications.
Daily visits during conditioning regimen
Duration - 2 years
Participants are monitored for outcomes including graft-versus-host disease, relapse, survival, and immune reconstitution over a 2-year period following transplantation.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 18 locations
1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Actively Recruiting
2
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
4
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
5
Xiangya Hospital Central South University
Changsha, Hunan, China
Actively Recruiting
6
Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)
Nanjing, Jiangsu, China
Actively Recruiting
7
Qilu Hospital of Shandong University
Jinan, Shandong, China
Actively Recruiting
8
the First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 311121
Actively Recruiting
9
Zhejiang Cancer Hospital & Hangzhou Institute of Medicine, Chinese Academy of Sciences
Hangzhou, Zhejiang, China
Actively Recruiting
10
Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Chongqing, China
Actively Recruiting
11
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
12
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)
Hangzhou, China
Actively Recruiting
13
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
14
Zhejiang Provincial Peoples's Hospital
Hangzhou, China
Actively Recruiting
15
The Affiliated People's Hospital of Ningbo University
Ningbo, China
Actively Recruiting
16
The First Affiliated Hospital of Ningbo University
Ningbo, China
Actively Recruiting
17
Shanghai General Hospital (Shanghai First People's Hospital)
Shanghai, China
Actively Recruiting
18
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Actively Recruiting
Research Team
Y
Yi Luo, Professor
P
Panpan Zhu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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