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Study identifier: NCT07396480 Synced from ClinicalTrials.gov · July 29, 2026
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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

Condition: Venentoclax · Myeloid Malignancies · Conditioning  ·  Sponsor: First Affiliated Hospital of Zhejiang University

PhasePhase 3
Planned participants186
Who can joinAll sexes, 50 Years to 75 Years
Healthy volunteersNo

About this study

Allogeneic Hematopoietic Cell Transplantation (Allo-HCT) serves as a curative treatment modality for the vast majority of patients with hematological malignancies. Historically, due to the relatively high treatment-related mortality rate associated with Allo-HCT, this therapy was primarily administered to younger patients. However, the median age at onset of most hematological malignancies falls within the elderly population. For instance, the median ages at onset of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) are 68 and 77 years, respectively. In recent years, with the advancement of transplantation techniques and the application of Reduced-intensity Conditioning (RIC) regimens, a growing number of elderly patients have undergone Allo-HCT. Data from the Center for International Blood and Marrow Transplant Research (CIBMTR) indicate that in 2017, 31% of patients who received Allo-HCT were aged over 60 years, and 6% were over 70 years old. Over the past decade, the number of elderly patients undergoing Allo-HCT has increased significantly. Given that most elderly patients cannot tolerate conventional myeloablative conditioning regimens, RIC regimens based on Fludarabine (Flu) combined with Busulfan (Bu), or Fludarabine (Flu) combined with Melphalan (Mel) are currently widely used in elderly patients undergoing Allo-HCT. Nevertheless, the post-transplant relapse rate remains as high as 30%-55%, and the long-term GVHD-free and Relapse-free Survival (GRFS) ra…

This description comes directly from the study's public registry record.

Talk to the study team

Yi Luo, Professor  ·  0571 87233801  ·  luoyijr@zju.edu.cn

Panpan Zhu  ·  +86 15825439779  ·  zhpanpan@zju.edu.cn

Always discuss trial participation with your own doctor first.

Locations (18)

The First Affiliated Hospital of Fujian Medical UniversityFuzhou, Fujian, ChinaRecruiting
Nanfang Hospital Southern Medical UniversityGuangzhou, Guangdong, ChinaRecruiting
The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, Henan, ChinaRecruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, Hubei, ChinaRecruiting
Xiangya Hospital Central South UniversityChangsha, Hunan, ChinaRecruiting
Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)Nanjing, Jiangsu, ChinaRecruiting
Qilu Hospital of Shandong UniversityJinan, Shandong, ChinaRecruiting
the First Affiliated Hospital, Zhejiang University School of MedicineHangzhou, Zhejiang, ChinaRecruiting
Zhejiang Cancer Hospital & Hangzhou Institute of Medicine, Chinese Academy of SciencesHangzhou, Zhejiang, ChinaRecruiting
Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)Chongqing, ChinaRecruiting
Sir Run Run Shaw Hospital Zhejiang University School of MedicineHangzhou, ChinaRecruiting
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)Hangzhou, ChinaRecruiting

+ 6 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07396480