Status:
RECRUITING
Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
16-55 years
Phase:
PHASE3
Brief Summary
Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15\~20%. More recently...
Detailed Description
Fludarabine and busulfan was considered as myeloablative but reduced toxicity regimen and became as the mainstay of conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelody...
Eligibility Criteria
Inclusion
- acute myeloid leukemia (acute promyelocytic leukemia excluded) in 1st complete remission
- myelodysplasia syndrome with bone marrow blast \>5% and remaining less than 20% at transplantation
- patients with HLA matched sibling donor, 9-10 matched unrelated donor or haplo-identical related donors
- inform consent provided
Exclusion
- AML patients with active CNS or extramedullary diseases
- patients with active viral, bacterial or fungal infection
- patients with hepatitis B virus \>1X103 copy/ml
- patients with abnormal liver function, renal function, respiratory or cardiac dysfunction
- patients with uncontrolled mental disorders
- patients with HIV
Key Trial Info
Start Date :
October 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT05991908
Start Date
October 19 2023
End Date
June 30 2026
Last Update
February 18 2025
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
2
Zhongshan Hospital, Xianmen University
Xiamen, Fujian, China, 361004
3
923th Hospital PLA
Nanning, Guangxi, China, 530021
4
First Affiliated Hospital of Nanjin Medical Unviersity
Nanjin, Jiangsu, China, 210029