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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

RecruitingPhase 3Ages 50 Years - 75 YearsAllFirst Affiliated Hospital of Zhejiang University
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In plain words

What the trial is, and whether it could suit you

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 r

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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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What it tests

  • Venetoclax in combination with fludarabine and melphalan
  • Fludarabine and Melphalan
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Where

18 sites
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Nanfang Hospital Southern Medical University
Guangzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Xiangya Hospital Central South University
Changsha, China
Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)
Nanjing, China
Qilu Hospital of Shandong University
Jinan, China
the First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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