Status:
UNKNOWN
Pharmacokinetic Study of Busulfan in Allogeneic Stem Cell Transplantation in Adult Patients With Acute Leukemia
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Acute Leukemia
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
Intravenous Busulfan (iv-Bu) is commonly used as part of preparation regimen for allogeneic hematopoietic stem cell transplantation for patients with acute leukemia. Though the pharmacokinetics data a...
Detailed Description
All patients received intravenous Busulfan based conditioning regimen for allogeneic stem cell transplantation. Intravenous Busulfan (iv-Bu) was given 1.6mg/kg twice daily for 4 days as in the condit...
Eligibility Criteria
Inclusion
- patient with acute myeloid or lymphoblastic leukemia in 1st or second remission
- age 18-55 years
- with inform consent
- no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
- HLA matched related (6/6) or unrelated donors (at least 8/10)
Exclusion
- age less than 18 years or over 56 years
- HLA mismatched related donor
- liver function/renal function damage (over 2 X upper normal range)
- with mental disease
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01498016
Start Date
November 1 2011
End Date
June 1 2022
Last Update
May 21 2021
Active Locations (1)
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1
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, China, 200025