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.
Aged between 60 and 69 years old (inclusive), gender not restricted.
Patients with hematological malignancies who plan to receive a single unrelated umbilical cord blood transplantation treatment
Serum creatinine ≤ 1.5 × ULN
Cardiac function: Ejection fraction > 50%
For those who are allergic to the drugs and their related metabolites
Any unstable systemic diseases: including but not limited to stable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 3 months before screening), myocardial infarction (within 3 months before screening), congestive heart failure (NYHA classification ≥ 3), severe arrhythmias requiring drug treatment, liver, kidney or metabolic diseases; patients with pulmonary hypertension; or diseases that, in the judgment of the investigator, pose a serious threat to the safety of the patient or affect the patient's ability to complete the study.
Active and uncontrolled infection: Hemodynamic instability related to the infection, or new symptoms or signs of infection appear, or new infection lesions are found on imaging, or persistent fever without symptoms or signs that cannot rule out the presence of an infection.
The patient is currently involved in a clinical intervention study
Single group
Thiotepa
DrugThiotepa 5 mg/kg every 12 hours, D-8.
Fludarabine
DrugFludarabine 30 mg/m2 per day, from D-7 to -4.
G-CSF
DrugG-CSF 5 ug/kg per day, from D-8 to D-5.
cytarabine
DrugCytarabine 1.5 g/m2, from D-7 to D-5.
busulfan
DrugBusulfan 0.8 mg/kg, every 6 hours, from D-4 to -2.
180-day non-recurrence mortality rate
The cumulative implantation rate of neutrophils
The cumulative implantation rate of platelets
The cumulative implantation time of platelets
The cumulative implantation time of neutrophils
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This trial is not recruiting at the moment. You can still explore other options:
