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The Safety and Efficacy of the Regimen of Thiotepa + Fludarabine +Granulocyte Colony-Stimulating Factor+ Cytarabine + Busulfan in Single Unrelated Umbilical Cord Blood Transplantation
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
This trial is a prospective, single-arm, single-center clinical study. A total of 44 elderly (aged 60 to 69 years) patients with hematological malignancies who need to receive a single-unit unrelated umbilical cord blood transplantation (UCBT) are planned to be enrolled. After screening and enrollment, patients are scheduled to receive the following drug treatment regimen: Thiotepa 5 mg/kg every 12 hours on day -8; Granulocyte Colony-Stimulating Factor(G-CSF) 5 ug/kg/day from day -8 to -5; Cytarabine 1.5 g/m2 from day -7 to -5; Fludarabine 30 mg/m2/day from day -7 to -4; Busulfan 0.8 mg/kg every 6 hours from day -4 to -2. Umbilical cord blood hematopoietic stem cells are reinfused on day 0. Routine monitoring of blood routine is conducted, and platelets and red blood cells are transfused when necessary.
Official title: A Prospective, Single-arm, Single-center, Open-label Clinical Study on the Safety and Efficacy of the Regimen of Thiotepa + Fludarabine +Granulocyte Colony-Stimulating Factor+ Cytarabine + Busulfan in Single Unrelated Umbilical Cord Blood Transplantation for Elderly Patients With Hematologic Malignancies
Key Details
Gender
All
Age Range
60 Years - 69 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2026-02-20
Completion Date
2028-12-30
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
Thiotepa
Thiotepa 5 mg/kg every 12 hours, D-8.
Fludarabine
Fludarabine 30 mg/m2 per day, from D-7 to -4.
G-CSF
G-CSF 5 ug/kg per day, from D-8 to D-5.
cytarabine
Cytarabine 1.5 g/m2, from D-7 to D-5.
busulfan
Busulfan 0.8 mg/kg, every 6 hours, from D-4 to -2.