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
Study ID
NCT07441967
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Hematologic Malignancies

Eligibility Criteria

Sex
ALL
Age
60 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Mar 2, 2026
Start date
Feb 20, 2026
Status verified
Feb 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Thiotepa + fludarabine + G-CSF + cytarabine + busulfan

Primary Outcome Measure

180-day non-recurrence mortality rate [ Time Frame: 180-day ]

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