NCT07441967

The Safety and Efficacy of the Regimen of Thiotepa + Fludarabine +Granulocyte Colony-Stimulating Factor+ Cytarabine + Busulfan in Single Unrelated Umbilical Cord Blood Transplantation

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 60 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	Thiotepa	Thiotepa 5 mg/kg every 12 hours, D-8.
DRUG	Fludarabine	Fludarabine 30 mg/m2 per day, from D-7 to -4.
DRUG	G-CSF	G-CSF 5 ug/kg per day, from D-8 to D-5.
DRUG	cytarabine	Cytarabine 1.5 g/m2, from D-7 to D-5.
DRUG	busulfan	Busulfan 0.8 mg/kg, every 6 hours, from D-4 to -2.

Timeline

• Start date: 2026-02-20
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2026-03-02
• Last updated: 2026-03-02